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(b) Aluminum sulfate, 46 to 63 percent (the concentration is based on the anhydrous equivalent).

(c) Witch hazel.

(58 FR 54462, Oct. 21, 1993, as amended at 59 FR 28768, June 3, 1994)

8 347.50 Labeling of astringent drug

products. (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “astringent.'

(b) Indications. The labeling of the product states, under the heading “Indications" any of the phrases listed in this paragraph (b), as appropriate. Other

truthful and nonmisleading statements describing only the indications for use that have been established and listed in this paragraph (b) may also be used, as provided in $330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) For products containing aluminum acetate identified in $347.10(a). “For temporary relief of minor skin irritations due to" (select one or more of the following: "poison ivy," "poison oak,' "poison sumac, " "insect bites," "athlete's foot,” or “rashes caused by soaps, detergents, cosmetics, or jewelry”).

(2) For products containing aluminum sulfate identified in § 347.10(b) for use as a styptic pencil. “Stops bleeding caused by minor surface cuts and abrasions as may occur during shaving."

(3) For products containing witch hazel identified in 347.10(c). (i) “For relief of minor skin irritations due to” (select one or more of the following: “insect bites," "minor cuts,"

"minor scrapes”).

(c) Warnings. The labeling of the product contains the following warnings under the heading "Warnings”:

(1) “For external use only. Avoid contact with the eyes.”

(2) For products containing aluminum acetate identified in $ 347.10(a) or witch hazel identified in $347.10(c). “If condi

tion worsens or symptoms persist for more than 7 days, discontinue use of the product and consult a" (select one of the following: "physician" or "doctor”').

(3) For products containing aluminum acetate identified in $347.10(a) used as a compress or wet dressing. “Do not cover compress or wet dressing with plastic to prevent evaporation."

(d) Directions. The labeling of the product contains the following information under the heading “Directions":

(1) For products containing aluminum acetate identified in § 347.10(a)(i) For products used as a soak. “For use as a soak: Soak affected area in the solution for 15 to 30 minutes. Discard solution after each use. Repeat 3 times a day.

(ii) For products used as a compress or wet dressing. “For use as a compress or wet dressing: saturate a clean, soft, white cloth (such as a diaper or torn sheet) in the solution, gently squeeze, and apply loosely to the affected area. Saturate the cloth in the solution every 15 to 30 minutes and apply to the affected area. Discard solution after each use. Repeat as often as necessary.

(2) For products containing aluminum sulfate identified in $347.10(6) for use as a styptic pencil. Moisten tip of pencil with water and apply to the affected area. Dry pencil after use."

(3) For products containing witch hazel identified in 347.10(C). “Apply to the affected area as often as necessary."

(58 FR 54462, Oct. 21, 1993, as amended at 59 FR 28768, June 3, 1994)

PART 348_EXTERNAL ANALGESIC

DRUG PRODUCTS FOR OVER-THECOUNTER HUMAN USE

Subpart A-General Provisions

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products.

AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

SOURCE: 57 FR 27656, June 19, 1992, unless otherwise noted.

Subpart A-General Provisions

8348.1 Scope.

(a) An over-the-counter external analgesic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in $330.1 of this chapter.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

8 348.3 Definitions.

As used in this part:

(a) Male genital desensitizing drug product. A drug product applied to the penis to help in temporarily slowing the onset of ejaculation.

(b) [Reserved]

(b) Indications. The labeling of the product states, under the heading “Indications," any of the phrases listed in paragraph (b) of this section. Other truthful

and nonmisleading statements, describing only the indications for use that have been established and listed in paragraph (b) of this section, may also be used, as provided in 8330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) For products containing any ingredient identified in $ 348.10(a). (i) “Helps in the prevention of premature ejaculation."

(ii) "For temporary male genital desensitization, helping to slow the onset of ejaculation."

(iii) "Helps in temporarily” (select one of the following: “retarding the onset of," "slowing the onset of," or "prolonging the time until") followed by "ejaculation."

(iv) “For reducing oversensitivity in the male in advance of intercourse."

(2) (Reserved]

(c) Warnings. The labeling of the product contains the following warnings under the heading "Warnings”:

(1) For products containing any ingredient identified in $ 348.10(a). (1) "Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed, does not provide relief, discontinue use and consult a doctor."

(ii) "Avoid contact with the eyes."

(iii) “If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor."

(2) [Reserved]

(d) Directions. The labeling of the product contains the following information under the heading “Directions":

(1) For products containing any ingredient identified in $ 348.10(a)–(1) For products containing benzocaine identified in $ 348.10(a)(1). “Apply a small amount to

Subpart B-Active Ingredients

8348.10 Analgesic, anesthetic, and

antipruritic active ingredients. The active ingredient of the product consists of any of the following within the specified concentration established for each ingredient:

(a) Male genital desensitizers. (1) Benzocaine, 3 to 7.5 percent in a watersoluble base.

(2) Lidocaine in a metered spray with approximately 10 milligrams per spray.

(b) [Reserved]

Subpart C-Labeling

§ 348.50 Labeling of external analgesic

drug products. (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as follows:

(1) For products containing any ingredient identified in 8 348.10(a). "Male genital desensitizer."

(2) (Reserved]

Subpart A--General Provisions

head and shaft of penis before intercourse, or use as directed by a doctor. Wash product off after intercourse.'

(ii) For products containing lidocaine identified in $348.10(a)(2). “Apply 3 or more sprays, not to exceed 10, to head and shaft of penis before intercourse, or use as directed by a doctor. Wash product off after intercourse.'

(2) [Reserved]

(e) The word "physician” may be substituted for the word "doctor" in any of the labeling statements in this section.

8349.1 Scope.

(a) An over-the-counter ophthalmic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in 8330.1.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

PART 349-OPHTHALMIC DRUG

PRODUCTS FOR OVER-THECOUNTER HUMAN USE

Subpart A-General Provisions

Sec. 349.1 Scope. 349.3 Definitions.

Subpart B-Active ingredients

349.10 Ophthalmic astringent. 349.12 Ophthalmic demulcents. 349.14 Ophthalmic emollients. 349.16 Ophthalmic hypertonicity agent. 349.18 Ophthalmic vasoconstrictors. 349.20 Eyewashes. 349.30 Permitted combinations of active in

gredients.

Subpart C-Labeling

$ 349.3 Definitions.

As used in this part:

(a) Ophthalmic drug product. A drug product, which should be sterile in accordance with $200.50, to be applied to the eyelid or instilled in the eye.

(b) Astringent. A locally acting pharmacologic agent which, by precipitating protein, helps to clear mucus from the outer surface of the eye.

(c) Buffering agent. A substance which stabilizes the pH of solutions against changes produced by introduction of acids or bases from such sources as drugs, body fluids, tears, etc.

(d) Demulcent. An agent, usually a water-soluble polymer, which is applied topically to the eye to protect and lubricate mucous membrane surfaces and relieve dryness and irritation.

(e) Emollient. An agent, usually a fat or oil, which is applied locally to eyelids to protect or soften tissues and to prevent drying and cracking.

(f) Eyewash, eye lotion, irrigating solution. A sterile aqueous solution intended for washing, bathing, or flushing the eye.

(g) Hypertonicity agent. An agent which exerts an osmotic gradient greater than that present in body tissues and fluids, so that water is drawn from the body tissues and fluids across semipermeable membranes. Applied topically to the eye, a hypertonicity agent creates an osmotic gradient which draws water out of the cornea.

(h) Isotonicity. A state or quality in which the osmotic pressure in two fluids is equal.

(i) Vasoconstrictor. A pharmacologic agent which, when applied topically to the mucous membranes of the eye,

349.50 Labeling of ophthalmic drug prod

ucts. 349.55 Labeling of ophthalmic astringent

drug products. 349.60 Labeling of ophthalmic demulcent

drug products. 349.65 Labeling of ophthalmic emollient

drug products. 349.70 Labeling of ophthalmic hypertonicity

drug products. 349.75 Labeling of ophthalmic vasoconstric

tor drug products. 349.78 Labeling of eyewash drug products. 349.79 Labeling of permitted combinations

of active ingredients. 349.80 Professional labeling.

AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

SOURCE: 53 FR 7090, Mar. 4, 1988, unless otherwise noted.

causes transient constriction of conjunctival blood vessels.

Subpart B-Active Ingredients

8 349.10 Ophthalmic astringent.

The active ingredient and its concentration in the product is as follows: Zinc sulfate, 0.25 percent.

(3) Paraffin, up to 5 percent in combination with one or more other emollient agents included in the monograph.

(4) Petrolatum, up to 100 percent. (5) White ointment, up to 100 percent.

(6) White petrolatum, up to 100 percent.

(7) White wax, up to 5 percent in combination with one or more other emollient agents included in the monograph.

(8) Yellow wax, up to 5 percent in combination with one or more other emollient agents included in the monograph.

$ 349.16 Ophthalmic hypertonicity

agent. The active ingredient and its concentration in the product is as follows: Sodium chloride, 2 to 5 percent.

8 349.12 Ophthalmic demulcents.

The active ingredients of the product consist of any of the following, within the established concentrations for each ingredient:

(a) Cellulose derivatives:

(1) Carboxymethylcellulose sodium, 0.2 to 2.5 percent.

(2) Hydroxyethyl cellulose, 0.2 to 2.5 percent.

(3) Hydroxypropyl methylcellulose, 0.2 to 2.5 percent.

(4) Methylcellulose, 0.2 to 2.5 percent.

(b) Dextran 70, 0.1 percent when used with another polymeric demulcent agent in this section.

(c) Gelatin, 0.01 percent.
(d) Polyols, liquid:
(1) Glycerin, 0.2 to 1 percent.

(2) Polyethylene glycol 300, 0.2 to 1 percent.

(3) Polyethylene glycol 400, 0.2 to 1 percent.

(4) Polysorbate 80, 0.2 to 1 percent. (5) Propylene glycol, 0.2 to 1 percent. (e) Polyvinyl alcohol, 0.1 to 4 percent. (f) Povidone, 0.1 to 2 percent.

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$ 349.14 Ophthalmic emollients.

The active ingredients of the product consist of any of the following:

(a) Lanolin preparations:

(1) Anhydrous lanolin, 1 to 10 percent in combination with one or more oleaginous emollient agents included in the monograph.

(2) Lanolin, 1 to 10 percent in combination with one or more oleaginous emollient agents included in the monograph.

(b) Oleaginous ingredients:

(1) Light mineral oil, up to 50 percent in combination with one or more other emollient agents included in the monograph.

(2) Mineral oil, up to 50 percent in combination with one or more other emollient agents included in the monograph.

8 349.30 Permitted combinations of ac

tive ingredients. The following combinations are permitted provided each active ingredient is present within the established concentration, and the product is labeled in accordance with $ 349.79.

(a) Any single ophthalmic astringent active ingredient identified in $349.10 may be combined with any single ophthalmic vasoconstrictor active ingredient identified in 8349.18.

(b) Any two or three ophthalmic demulcent active ingredients identified in 8 349.12 may be combined.

(c) Any single ophthalmic demulcent active ingredient identified in $349.12 or any ophthalmic demulcent combination identified in paragraph (b) of this section may be combined with any single ophthalmic vasoconstrictor identified in 8349.18.

(d) Any single ophthalmic astringent active ingredient identified in $349.10 may be combined with any single ophthalmic vasoconstrictor active ingredient identified in 8349.18 and any single ophthalmic demulcent identified in $349.12 or ophthalmic demulcent combination identified in paragraph (b) of this section.

(e) Any two or more emollient active ingredients identified in 8 349.14 may be combined as necessary to give the product proper consistency for application to the eye.

(2) For ophthalmic drug products packaged in single-use containers. “To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.'

(3) For ophthalmic drug products containing mercury compounds used as a preservative. “This product contains (name and quantity of mercury-containing ingredient) as a preservative. Do not use this product if you are sensitive to" (select one of the following: "mercury" or "(insert name of mercury-containing ingredient) or any other ingredient containing mercury).

Subpart C-Labeling

8 349.50 Labeling of ophthalmic drug

products. (a) The word "physician" may be substituted for the word "doctor" in any of the labeling statements in this part.

(b) Where applicable, indications in this part applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this part, may also be used, as provided in $330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(c) The labeling of the product contains the following warnings, under the heading "Warnings":

(1) For ophthalmic drug products packaged in multi-use containers. “To avoid contamination, do not touch tip of container to any surface. Replace cap after using."

349.55 Labeling of ophthalmic astrin

gent drug products. (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an "astringent" (select one of the following: "eye” or “ophthalmic") "(insert dosage form, e.g., drops).

(b) Indications. The labeling of the product states, under the heading "Indications,” the following phrase: "For the temporary relief of discomfort from minor eye irritations."

(c) Warnings. In addition to the warnings in $349.50, the labeling of the product contains the following warnings under the heading “Warnings" for products containing any ingredient identified in $349.10:

(1) “If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor."

(2) "If solution changes color or becomes cloudy, do not use.

(d) Directions. The labeling of the product contains the following information under the heading "Directions": Instill 1 to 2 drops in the affected eye(s) up to four times daily.

§ 349.60 Labeling of ophthalmic demul

cent drug products. (a) Statement of identity. The labeling of the product contains the established name of the drug(s), if any, and identifies the product as a “lubricant” or "demulcent (lubricant)" (select one of the following: "eye” or “ophthalmic") "(insert dosage form, e.g., drops)."

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