[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR310.201]

[Page 11-18]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 310--NEW DRUGS--Table of Contents
 
 Subpart C--New Drugs Exempted From Prescription-Dispensing Requirements
 
Sec. 310.201  Exemption for certain drugs limited by new-drug applications to prescription sale.

    (a) The prescription-dispensing requirements of section 503(b)(1)(C) 
of the Federal Food, Drug, and Cosmetic Act are not necessary for the 
protection of the public health with respect to the following drugs 
subject to new drug applications:
    (1) N-Acetyl-p-aminophenol (acetaminophen, p-hydroxy-acetanilid) 
preparations meeting all the following conditions:
    (i) The N-acetyl-p-aminophenol is prepared, with or without other 
drugs, in tablet or other dosage form suitable for oral use in self-
medication, and containing no drug limited to prescription sale under 
the provisions of section 503(b)(1) of the act.
    (ii) The N-acetyl-p-aminophenol and all other components of the 
preparation meet their professed standards of identity, strength, 
quality, and purity.
    (iii) If the preparation is a new drug, an application pursuant to 
section 505 (b) of the act is approved for it.
    (iv) The preparation contains not more than 0.325 gram (5 grains) of 
N-acetyl-p-aminophenol per dosage unit, or if it is in liquid form not 
more than 100 milligrams of N-acetyl-p-aminophenol per milliliter.
    (v) The preparation is labeled with adequate directions for use in 
minor conditions as a simple analgesic.
    (vi) The dosages of N-acetyl-p-aminophenol recommended or suggested 
in the labeling do not exceed: For adults, 0.65 gram (10 grains) per 
dose or 2.6 grams (40 grains) per 24-hour period: for children 6 to 12 
years of age, one-half of the maximum adult dose or dosage; for children 
3 to 6 years of age, one-fifth of the maximum adult dose or dosage.
    (vii) The labeling bears, in juxtaposition with the dosage 
recommendations, a clear warning statement against administration of the 
drug to children under 3 years of age and against use of the drug for 
more than 10 days, unless such uses are directed by a physician.
    (viii) If the article is offered for use in arthritis or rheumatism, 
the labeling prominently bears a statement that the beneficial effects 
claimed are limited to the temporary relief of minor aches and pains of 
arthritis and rheumatism and, in juxtaposition with directions for use 
in such conditions, a conspicuous warning statement, such as ``Caution: 
If pain persists for more than 10 days, or redness is present, or in 
conditions affecting children under 12 years of age, consult a physician 
immediately''.
    (2) Sodium gentisate (sodium-2, 5-dihydroxybenzoate) preparations 
meeting all the following conditions:
    (i) The sodium gentisate is prepared, with or without other drugs, 
in tablet or other dosage form suitable for oral use in self-medication, 
and containing no drug limited to prescription sale under the provisions 
of section 503(b)(1) of the act.
    (ii) The sodium gentisate and all other components of the 
preparation meet their professed standards of identity, strength, 
quality, and purity.
    (iii) If the preparation is a new drug, an application pursuant to 
section 505(b) of the act is approved for it.
    (iv) The preparation contains not more than 0.5 gram (7.7 grains) of 
anhydrous sodium gentisate per dosage unit.
    (v) The preparation is labeled with adequate directions for use in 
minor conditions as a simple analgesic.
    (vi) The dosages of sodium gentisate recommended or suggested in the 
labeling do not exceed: For adults, 0.5 gram (7.7 grains) per dose of 
2.0 grams (31 grains) per 24-hour period; for children 6 to 12 years of 
age, one-half of the maximum adult dose or dosage.
    (vii) The labeling bears, in juxtaposition with the dosage 
recommendations,

[[Page 12]]

a clear warning statement against administration of the drug to children 
under 6 years of age and against use of the drug for a prolonged period, 
except as such uses may be directed by a physician.
    (3) Isoamylhydrocupreine and zolamine hydrochloride (N, N-dimethyl-
N'-2-thiazolyl-N'-p-methoxybenzyl-ethyl- enediamine hydrochloride) 
preparations meeting all the following conditions:
    (i) The isoamylhydrocupreine and zolamine hydrochloride are prepared 
in dosage form suitable for self-medication as rectal suppositories or 
as an ointment and containing no drug limited to prescription sale under 
the provisions of section 503(b)(1) of the act.
    (ii) The isoamylhydrocupreine, zola-amine hydrochloride, and all 
other components of the preparation meet their professed standards of 
identity, strength, quality, and purity.
    (iii) If the preparation is a new drug, an application pursuant to 
section 505(b) of the act is approved for it.
    (iv) The preparation contains not more than 0.25 percent of 
isoamylhydrocupreine and 1.0 percent of zolamine hydrochloride.
    (v) If the preparation is in suppository form, it contains not more 
than 5.0 milligrams of isoamylhydrocupreine and not more than 20.0 
milligrams of zolamine hydrochloride per suppository.
    (vi) The preparation is labeled with adequate directions for use in 
the temporary relief of local pain and itching associated with 
hemorrhoids.
    (vii) The directions provide for the use of not more than two 
suppositories or two applications of ointment in a 24-hour period.
    (viii) The labeling bears, in juxtaposition with the dosage 
recommendations, a clear warning statement against use of the 
preparation in case of rectal bleeding, as this may indicate serious 
disease.
    (4) Phenyltoloxamine dihydrogen citrate (N,N-dimethyl-(a-phenyl-O-
toloxy) ethylamine dihydrogen citrate), preparations meeting all the 
following conditions:
    (i) The phenyltoloxamine dihydrogen citrate is prepared, with or 
without other drugs, in tablet or other dosage form suitable for oral 
use in self-medication, and containing no drug limited to prescription 
sale under the provisions of section 503(b)(1) of the act.
    (ii) The phenyltoloxamine dihydrogen citrate and all other 
components of the preparation meet their professed standards of 
identity, strength, quality, and purity.
    (iii) If the preparation is a new drug, an application pursuant to 
section 505(b) of the act is approved for it.
    (iv) The preparation contains not more than 88 milligrams of 
phenyltoloxamine dihydrogen citrate (equivalent to 50 milligrams of 
phenyltoloxamine) per dosage unit.
    (v) The preparation is labeled with adequate directions for use in 
the temporary relief of the symptoms of hay fever and/or the symptoms of 
other minor conditions in which it is indicated.
    (vi) The dosages recommended or suggested in the labeling do not 
exceed: For adults, 88 milligrams of phenyltoloxamine dihydrogen citrate 
(equivalent to 50 milligrams of phenyltoloxamine) per dose or 264 
milligrams of phenyltoloxamine dihydrogen citrate (equivalent to 150 
milligrams of phenyltoloxamine) per 24-hour period; for children 6 to 12 
years of age, one-half of the maximum adult dose or dosage.
    (vii) The labeling bears, in juxtaposition with the dosage 
recommendations:
    (a) Clear warning statements against administration of the drug to 
children under 6 years of age, except as directed by a physician, and 
against driving a car or operating machinery while using the drug, since 
it may cause drowsiness.
    (b) If the article is offered for temporary relief of the symptoms 
of colds, a statement that continued administration for such use should 
not exceed 3 days, except as directed by a physician.
    (5)-(7) [Reserved]
    (8) Dicyclomine hydrochloride (1-cyclohexylhexahydrobenzoic acid. 
[beta]-diethylaminoethyl ester hydrochloride; diethylaminocarbethoxy-
bicyclohexyl hydrochloride) preparations meeting all the following 
conditions:
    (i) The dicyclomine hydrochloride is prepared with suitable antacid 
and other components, in tablet or other

[[Page 13]]

dosage form for oral use in self-medication, and containing no drug 
limited to prescription sale under the provisions of section 503(b)(1) 
of the act.
    (ii) The dicyclomine hydrochloride and all other components of the 
preparation meet their professed standards of identity, strength, 
quality, and purity.
    (iii) If the preparation is a new drug, an application pursuant to 
section 505(b) of the act is approved for it.
    (iv) The preparation contains not more than 5 milligrams of 
dicyclomine hydrochloride per dosage unit, or if it is in liquid form 
not more than 0.5 milligram of dicyclomine hydrochloride per milliliter.
    (v) The preparation is labeled with adequate directions for use only 
by adults and children over 12 years of age, in the temporary relief of 
gastric hyperacidity.
    (vi) The dosages recommended or suggested in the directions for use 
do not exceed 10 milligrams of dicyclomine hydrochloride per dose or 30 
milligrams in a 24-hour period.
    (vii) The labeling bears, in juxtaposition with the dosage 
recommendations, clear warning statements against:
    (a) Exceeding the recommended dosage.
    (b) Prolonged use, except as directed by a physician, since 
persistent or recurring symptoms may indicate a serious disease 
requiring medical attention.
    (c) Administration to children under 12 years of age except as 
directed by a physician.
    (9)-(10) [Reserved]
    (11) Hexadenol (a mixture of tetracosanes and their oxidation 
products) preparations meeting all the following conditions:
    (i) The hexadenol is prepared and packaged, with or without other 
drugs, solvents, and propellants, in a form suitable for self-medication 
by external application to the skin as a spray, and containing no drug 
limited to prescription sale under the provisions of section 503(b)(1) 
of the act.
    (ii) The hexadenol and all other components of the preparation meet 
their professed standards of identity, strength, quality, and purity.
    (iii) If the preparation is a new drug, an application pursuant to 
section 505(b) of the act is approved for it.
    (iv) The preparation contains not more than 5 percent by weight of 
hexadenol.
    (v) The preparation is labeled with adequate directions for use by 
external application in the treatment of minor burns and minor skin 
irritations.
    (vi) The labeling bears, in juxtaposition with the directions for 
use, clear warning statements against:
    (a) Use on serious burns or skin conditions or prolonged use, except 
as directed by a physician.
    (b) Spraying the preparation in the vicinity of eyes, mouth, nose, 
or ears.
    (12) Sulfur dioxide preparations meeting all the following 
conditions:
    (i) The sulfur dioxide is prepared with or without other drugs, in 
an aqueous solution packaged in a hermetic container suitable for use in 
self-medication by external application to the skin, and containing no 
drug limited to prescription sale under the provisions of section 
503(b)(1) of the act.
    (ii) The sulfur dioxide and all other components of the preparation 
meet their professed standards of identity, strength, quality, and 
purity.
    (iii) If the preparation is a new drug, an application pursuant to 
section 505(b) of the act is approved for it.
    (iv) The preparation contains not more than 5 grams of sulfur 
dioxide per 100 milliliters of solution.
    (v) The preparation is labeled with adequate directions for use by 
external application to the smooth skin in the prevention or treatment 
of minor conditions in which it is indicated.
    (vi) The directions for use recommend or suggest not more than two 
applications a day for not more than 1 week, except as directed by a 
physician.
    (13)-(15) [Reserved]
    (16) Tuaminoheptane sulfate (2-aminoheptane sulfate) preparations 
meeting all the following conditions:
    (i) The tuaminoheptane sulfate is prepared, with or without other 
drugs, in an aqueous vehicle suitable for administration in self-
medication as nose drops, and containing no drug limited to prescription 
sale under the provisions of section 503(b)(1) of the act.

[[Page 14]]

    (ii) The preparation is packaged with a style of container or 
assembly suited to self-medication by the recommended route of 
administration, and delivering not more than 0.1 milliliter of the 
preparation per drop.
    (iii) The tuaminoheptane sulfate and all other components of the 
preparation meet their professed standards of identity, strength, 
quality, and purity.
    (iv) If the preparation is a new drug, an application pursuant to 
section 505(b) of the act is approved for it.
    (v) The tuaminoheptane sulfate content of the preparation does not 
exceed 10 milligrams per milliliter.
    (vi) The preparation is labeled with adequate directions for use in 
the temporary relief of nasal congestion.
    (vii) The dosages recommended or suggested in the directions for use 
do not exceed the equivalent: For adults, 5 drops of a 1 percent 
solution per nostril per dose, and 5 doses in a 24-hour period; for 
children 1 to 6 years of age, 3 drops of a 1 percent solution per 
nostril per dose, and 5 doses in a 24-hour period; for infants under 1 
year of age, 2 drops of a 1 percent solution per nostril per dose, and 5 
doses in a 24-hour period.
    (viii) The labeling bears, in juxtaposition with the dosage 
recommendations:
    (a) Clear warning statements against use of more than 5 doses daily, 
and against use longer than 4 days unless directed by a physician.
    (b) A clear warning statement to the effect that frequent use may 
cause nervousness or sleeplessness, and that individuals with high blood 
pressure, heart disease, diabetes, or thyroid disease should not use the 
preparation unless directed by a physician.
    (17) [Reserved]
    (18) Vibesate (a mixture of copolymers of hydroxy-vinyl 
chlorideacetate, sebacic acid, and modified maleic rosin ester) 
preparations meeting all the following conditions.
    (i) The vibesate is prepared and packaged, with or without other 
drugs, solvents, and propellants, in a form suitable for self-medication 
by external application to the skin as a spray, and containing no drug 
limited to prescription sale under the provisions of section 503(b)(1) 
of the act.
    (ii) The vibesate and all other components of the preparation meet 
their professed standards of identity, strength, quality, and purity.
    (iii) If the preparation is a new drug, an application pursuant to 
section 505(b) of the act is approved for it.
    (iv) The preparation contains not more than 13 percent by weight of 
vibesate.
    (v) The preparation is labeled with adequate directions for use by 
external application as a dressing for minor burns, minor cuts, or other 
minor skin irritations.
    (vi) The labeling bears in juxtaposition with the directions for use 
clear warning statements against:
    (a) Use on serious burns and on infected, deep, and puncture wounds 
unless directed by a physician.
    (b) Spraying the preparation near the eyes or other mucous 
membranes.
    (c) Inhaling the preparation.
    (d) Use near open flames.
    (e) Puncturing the container or throwing the container into fire.
    (19) Pramoxine hydrochloride (4-N-butoxyphenyl [gamma]-
morpholinopropyl ether hydrochloride) preparations meeting all the 
following conditions:
    (i) The pramoxine hydrochloride is prepared, with or without other 
drugs, in a dosage form suitable for use in self-medication by external 
application to the skin, and containing no drug limited to prescription 
sale under the provisions of section 503(b)(1) of the act.
    (ii) The pramoxine hydrochloride and all other components of the 
preparation meet their professed standards of identity, strength, 
quality, and purity.
    (iii) If the preparation is a new drug, an application pursuant to 
section 505(b) of the act is approved for it.
    (iv) The preparation contains not more than 1.0 percent of pramoxine 
hydrochloride.
    (v) The preparation is labeled with adequate directions for use by 
external application to the skin for the temporary relief of pain or 
itching due to minor burns and sunburn, nonpoisonous insect bites, and 
minor skin irritations.
    (vi) The directions for use recommend or suggest not more than four

[[Page 15]]

applications of the preparation per day, unless directed by a physician.
    (vii) The labeling bears, in juxtaposition with the directions for 
use, clear warning statements against:
    (a) Prolonged use.
    (b) Application to large areas of the body.
    (c) Continued use if redness, irritation, swelling, or pain persists 
or increases, unless directed by a physician.
    (d) Use in the eyes or nose.
    (20) Carbetapentane citrate (2-(2-diethylaminoethoxy)-ethyl-1-
phenyl- cyclopentyl-1-carboxylate citrate) preparations meeting all the 
following conditions:
    (i) The carbetanentane citrate is prepared, with or without other 
drugs, in tablet or other dosage form suitable for oral use in self-
medication, and containing no drug limited to prescription sale under 
the provisions of section 503(b)(1) of the act.
    (ii) The carbetapentane citrate and all other components of the 
preparation meet their professed standards of identity, strength, 
quality, and purity.
    (iii) If the preparation is a new drug, and application pursuant to 
section 505(b) of the act is approved for it.
    (iv) The preparation contains not more than 25 milligrams of 
carbetapentane citrate per dosage unit; or if it is in liquid form, not 
more than 1.5 milligrams of carbetapentane citrate per milliliter.
    (v) The preparation is labeled with adequate directions for use in 
the temporary relief of cough due to minor conditions in which it is 
indicated.
    (vi) The dosages recommended or suggested in the labeling do not 
exceed: For adults, 30 milligrams of carbetapentane citrate per dose or 
120 milligrams of carbetapentane citrate per 24-hour period; for 
children 4 to 12 years of age, 7.5 milligrams per dose or 30 milligrams 
per 24-hour period; for children 2 to 4 years of age, 4.0 milligrams per 
dose or 16.0 milligrams per 24-hour period.
    (vii) The label bears a conspicuous warning to keep the drug out of 
the reach of children, and the labeling bears, in juxtaposition with the 
dosage recommendations:
    (a) A clear warning statement against administration of the drug to 
children under 2 years of age, unless directed by a physician.
    (b) Clear warning statements against use of the drug in the presence 
of high fever or if cough persists, since persistent cough as well as 
high fever may indicate the presence of a serious condition.
    (21) Pamabrom (2-amino-2-methylpropanol-1-8-bromotheophyllinate) 
preparations meeting all the following conditions:
    (i) The pamabrom is prepared with appropriate amounts of a suitable 
analgesic and with or without other drugs, in tablet or other dosage 
form suitable for oral use in self-medication, and containing no drug 
limited to prescription sale under the provisions of section 503(b)(1) 
of the act.
    (ii) The pamabrom and all other components of the preparation meet 
their professed standards of identity, strength, quality, and purity.
    (iii) If the preparation is a new drug, an application pursuant to 
section 505(b) of the act is approved for it.
    (iv) The preparation contains not more than 50 milligrams of 
pamabrom per dosage unit.
    (v) The preparation is labeled with adequate directions for use in 
the temporary relief of the minor pains and discomforts that may occur a 
few days before and during the menstrual period.
    (vi) The dosages recommended or suggested in the labeling do not 
exceed 50 milligrams of pamabrom per dose or 200 milligrams per 24-hour 
period.
    (22) Diphemanil methylsulfate (4-diphenylmethylene-1,1-dimethyl-
piperidinium methylsulfate) preparations meeting all the following 
conditions:
    (i) The diphemanil methylsulfate is prepared, with or without other 
drugs, in a dosage form suitable for use in self-medication by external 
application to the skin, and containing no drug limited to prescription 
sale under the provisions of section 503(b)(1) of the act.
    (ii) The diphemanil methylsulfate and all other components of the 
preparation meet their professed standards of identity, strength, 
quality, and purity.

[[Page 16]]

    (iii) If the preparation is a new drug, an application pursuant to 
section 505(b) of the act is approved for it.
    (iv) The preparation contains not more than 2.0 percent of 
diphemanil methylsulfate.
    (v) The preparation is labeled with adequate directions for use by 
external application to the skin for the relief of symptoms of mild 
poison ivy, oak, and sumac and other minor irritations and itching of 
the skin.
    (vi) The directions for use recommend or suggest not more than four 
applications of the preparation per day, unless directed by a physician.
    (vii) The labeling bears, in juxtaposition with the directions for 
use, a clear warning statement, such as: ``Caution: If redness, 
irritation, swelling, or pain persists or increases, discontinue use and 
consult physician.''
    (23) Dyclonine hydrochloride (4-butoxy-3-piperidinopropiophenone 
hydrochloride; 4-n-butoxy-[beta]-piperidonopropiophenone hydrochloride) 
preparations meeting all the following conditions:
    (i) The dyclonine hydrochloride is prepared, with or without other 
drugs, in a dosage form suitable for use as a cream or ointment in self-
medication by external application to the skin, or rectally, and 
contains no drug limited to prescription sale under the provisions of 
section 503(b)(1) of the act.
    (ii) The dyclonine hydrochloride and all other components of the 
preparation meet their professed standards of identity, strength, 
quality, and purity.
    (iii) If the preparation is a new drug, an application pursuant to 
section 505(b) of the act is approved for it.
    (iv) The preparation contains not more than 1.0 percent of dyclonine 
hydrochloride.
    (v) The preparation is labeled with adequate directions for use:
    (a) By external application to the skin for the temporary relief of 
pain and itching in sunburn, nonpoisonous insect bites, minor burns, 
cuts, abrasions, and other minor skin irritations.
    (b) [Reserved]
    (c) In the prevention or treatment of other minor conditions in 
which it is indicated.
    (vi) The labeling bears, in juxtaposition with the directions for 
use, clear warning statements against:
    (a) Continued use if redness, irritation, swelling, or pain persists 
or increases, unless directed by a physician.
    (b) Use in case of rectal bleeding, as this may indicate serious 
disease.
    (c) Use in the eyes.
    (d) Prolonged use.
    (e) Application to large areas of the body.
    (f) Use for deep or puncture wounds or serious burns.
    (24) Chlorothen citrate (chloromethapyrilene citrate; N,N-dimethyl-
N'-(2-pyridyl)-N'-(5-chloro-2-thenyl) ethylenediamine citrate) 
preparations meeting all the following conditions:
    (i) The chlorothen citrate is prepared, with or without other drugs, 
in tablet or other dosage form suitable for oral use in self-medication, 
and containing no drug limited to prescription sale under the provisions 
of section 503(b)(1) of the act.
    (ii) The chlorothen citrate and all other components of the 
preparation meet their professed standards of identity, strength, 
quality, and purity.
    (iii) If the preparation is a new drug, an application pursuant to 
section 505(b) of the act is approved for it.
    (iv) The preparation contains not more than 25 milligrams of 
chlorothen citrate per dosage unit.
    (v) The preparation is labeled with adequate directions for use in 
the temporary relief of the symptoms of hay fever and/or the symptoms of 
other minor conditions in which it is indicated.
    (vi) The dosages recommended or suggested in the labeling do not 
exceed: For adults, 25 milligrams of chlorothen citrate per dose or 150 
milligrams of chlorothen citrate per 24-hour period; for children 6 to 
12 years of age, one-half of the maximum adult dose or dosage.
    (vii) The labeling bears, in juxtaposition with the dosage 
recommendations:
    (a) Clear warning statements against administration of the drug to 
children under 6 years of age or exceeding the recommended dosage, 
unless directed by a physician, and against driving a car or operating 
machinery while using

[[Page 17]]

the drug, since it may cause drowsiness.
    (b) If the article is offered for the temporary relief of symptoms 
of colds, a statement that continued administration for such use should 
not exceed 3 days, unless directed by a physician.
    (25) [Reserved]
    (26) Methoxyphenamine hydrochloride ([beta]-(o-methoxyphenyl)-
isopropyl-methylamine hydrochloride; 1-(o-methoxyphenyl)- 2-methylamino-
propane hydrochloride) preparations meeting all the following 
conditions:
    (i) The methoxyphenamine hydrochloride is prepared with appropriate 
amounts of a suitable antitussive, with or without other drugs, in a 
dosage form suitable for oral use in self-medication, and containing no 
drug limited to prescription sale under the provisions of section 
503(b)(1) of the act.
    (ii) The methoxyphenamine hydrochloride and all other components of 
the preparation meet their professed standards of identity, strength, 
quality, and purity.
    (iii) If the preparation is a new drug, an application pursuant to 
section 505(b) of the act is approved for it.
    (iv) The preparation contains not more than 3.5 milligrams of 
methoxyphenamine hydrochloride per milliliter.
    (v) The preparation is labeled with adequate directions for use in 
the temporary relief of cough due to minor conditions in which it is 
indicated.
    (vi) The dosages recommended or suggested in the labeling do not 
exceed: For adults, 35 milligrams of methoxyphenamine hydrochloride per 
dose or 140 milligrams of methoxyphenamine hydrochloride per 24-hour 
period; for children 6 to 12 years of age, one-half of the maximum adult 
dose or dosage.
    (vii) The label bears a conspicuous warning to keep the drug out of 
the reach of children, and the labeling bears, in juxtaposition with the 
dosage recommendations:
    (a) A clear warning statement against administration of the drug to 
children under 6 years of age, unless directed by a physician.
    (b) A clear warning statement to the effect that frequent or 
prolonged use may cause nervousness, restlessness, or drowsiness, and 
that individuals with high blood pressure, heart disease, diabetes, or 
thyroid disease should not use the preparation unless directed by a 
physician.
    (c) A clear warning statement against use of the drug in the 
presence of high fever or if cough persists, since persistent cough as 
well as high fever may indicate the presence of a serious condition.
    (27) Biphenamine hydrochloride ([beta]-diethylaminoethyl-3-phenyl-2-
hydroxybenzoate hydrochloride) preparations meeting all the following 
conditions:
    (i) The biphenamine hydrochloride is prepared in a form suitable for 
use as a shampoo and contains no drug limited to prescription sale under 
the provisions of section 503(b)(1) of the act.
    (ii) The biphenamine hydrochloride meets its professed standards of 
identity, strength, quality, and purity.
    (iii) If the preparation is a new drug, an application pursuant to 
section 505(b) of the act is approved for it.
    (iv) The preparation contains not more than 1 percent of biphenamine 
hydrochloride.
    (v) The preparation is labeled with adequate directions for use for 
the temporary relief of itching and scaling due to dandruff.
    (vi) The label bears a conspicuous warning to keep the drug out of 
the reach of children.
    (28) Tyloxapol (an alkylarylpolyether alcohol) and benzalkonium 
chloride ophthalmic preparations meeting all the following conditions:
    (i) The tyloxapol and benzalkonium chloride are prepared, with other 
appropriate ingredients which are not drugs limited to prescription sale 
under the provisions of section 503(b)(1) of the act, as a sterile, 
isotonic aqueous solution suitable for use in self-medication on eye 
prostheses.
    (ii) The preparation is so packaged as to volume and type of 
container as to afford adequate protection and be suitable for self-
medication with a minimum risk of contamination of the solution during 
use. Any dispensing unit is sterile and so packaged as to maintain 
sterility until the package is opened.
    (iii) The tyloxapol, benzalkonium chloride, and other ingredients 
used to prepare the isotonic aqueous solution

[[Page 18]]

meet their professed standards of identity, strength, quality, and 
purity.
    (iv) An application pursuant to section 505(b) of the act is 
approved for the drug.
    (v) The preparation contains 0.25 percent of tyloxapol and 0.02 
percent of benzalkonium chloride.
    (vi) The label bears a conspicuous warning to keep the drug out of 
the reach of children and the labeling bears, in juxtaposition with the 
dosage recommendations, a clear warning that if irritation occurs, 
persists, or increases, use of the drug should be discontinued and a 
physician consulted. The labeling includes a statement that the dropper 
or other dispensing tip should not touch any surface, since this may 
contaminate the solution.
    (29) [Reserved]
    (b) [Reserved]

[39 FR 11680, Mar. 29, 1974, as amended at 42 FR 36994, July 19, 1977; 
52 FR 15892, Apr. 30, 1987; 52 FR 30055, Aug. 12, 1987; 55 FR 31779, 
Aug. 3, 1990; 57 FR 58374, Dec. 9, 1992; 58 FR 49898, Sept. 23, 1993; 59 
FR 4218, Jan. 28, 1994; 60 FR 52507, Oct. 6, 1995]