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$ 357.801 Scope.

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

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

$ 357.803 Definitions.

As used in this subpart:

(a) Colostomy. An external operative opening of the colon.

(b) Deodorant for internal use. An ingredient taken internally to reduce odors arising from conditions such as colostomies, ileostomies, or fecal incontinence.

(c) lleostomy. An external operative opening from the ileum.

(d) Incontinence. An inability to retain urine or feces.

$ 357.810 Active ingredients for deo

dorant drug products for internal

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 bismuth subgallate identified in $ 357.810(a). An aid to reduce odor from a colostomy or ileostomy.”

(2) For products containing chlorophyllin copper complex identified in $ 357.81010). (i) “An aid to reduce odor from a colostomy or ileostomy."

(ii) “An aid to reduce fecal odor due to incontinence.”

(c) Warnings. The labeling of the product contains the following warnings under the heading "Warnings'': (1) For products containing chlorophyllin copper complex identified in $ 357.810(6). (i) "If cramps or diarrhea occurs, reduce the dosage. If symptoms persist, consult your doctor."

(ii) The warning required by $330.1(8) of this chapter concerning overdose is not required on products containing chlorophyllin copper complex identified in 8 357.810(b).

(2) (Reserved]

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

(1) For products containing bismuth subgallate identified in $ 357.810(a). Adults and children 12 years of age and over: Oral dosage is 200 to 400 milligrams up to 4 times daily. Children under 12 years of age: consult a doctor.

(2) For products containing chlorophyllin copper complex identified in $ 357.810(0). Adults and children 12 years of age and over: Oral dosage is 100 to 200 milligrams daily in divided doses as required. If odor is not controlled, take up to an additional 100 milligrams daily in divided doses as required. The smallest effective dose should be used. Do not exceed 300 milligrams daily. Children under 12 years of age: consult a doctor.

use,

The active ingredient of the product consists of either of the following when used within the dosage limits established for each ingredient in $357.850(d):

(a) Bismuth subgallate.
(b) Chlorophyllin copper complex.

$ 357.850 Labeling of deodorant drug

products for internal use. (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as a "deodorant for internal use" or as a "colostomy or ileostomy deodorant."

(b) Indications. The labeling of the product states, under the heading “Indications,” any of the phrases listed in paragraph (b) of this section as appropriate. 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 $330.1(c)(2) of this chapter, subject to the provisions of section 502

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358.701 Scope. 358.703 Definitions. 358.710 Active ingredients for the control of

dandruff, seborrheic dermatitis, or psori

asis. 358.720 Permitted combinations of active in

gredients. 358.750 Labeling of drug products for the

control of dandruff, seborrheic dermatitis, or psoriasis.

The product consists of any of the following active ingredients within the specified concentration and in the dosage form established for each ingredient.

(a) Salicylic acid 12 to 40 percent in a plaster vehicle.

(b) Salicylic acid 5 to 17 percent in a collodion-like vehicle.

(c) Salicylic acid 15 percent in a karaya gum, glycol plaster vehicle.

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

SOURCE: 55 FR 33255, Aug. 14, 1990, unless otherwise noted.

Subpart A [Reserved)

$ 358.150 Labeling of wart remover

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 a “wart remover.”

(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 in paragraph (b) of this section, 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,

Subpart B-Wart Remover Drug

Products

8358.101 Scope.

(a) An over-the-counter wart remover drug product in a form suitable for topical application is generally recognized

179070 0-98%-10

as

or

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 the removal of common warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface."

(2) “For the removal of plantar warts on the bottom of the foot. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern."

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

(1) For products containing any ingredient identified in § 358.110. (i) “For external use only."

(ii) "Do not use this product on irritated skin, on any area that is infected or reddened, if you are a diabetic, or if you have poor blood circulation."

(iii) “If discomfort persists, see your doctor."

(iv) “Do not use on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes."

(2) For any product formulated in a flammable vehicle. (i) The labeling should contain an appropriate flammability signal word, e.g. "extremely flammable," “flammable, "combustible, consistent with 16 CFR 1500.3(b)(10).

(ii) “Keep away from fire or flame."

(3) For any product formulated in a volatile vehicle. “Cap bottle tightly and store at room temperature away from heat."

(4) For any product formulated in a collodion-like vehicle. (i) “If product gets into the eye, flush with water for 15 minutes."

(ii) “Avoid inhaling vapors.'

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

(1) For products containing salicylic acid identified in $ 358.110(a). “Wash affected area.” (Optional: “May soak wart in warm water for 5 minutes.") “Dry area thoroughly.” (If appropriate:

“Cut plaster to fit wart.”) “Apply medicated plaster. Repeat procedure every 48 hours as needed (until wart is removed) for up to 12 weeks."

(2) For products containing salicylic acid identified in $358.110(6). Wash affected area." (Optional: “May soak wart in warm water for 5 minutes.") “Dry area thoroughly. Apply" (select one of the following, as appropriate: “one drop" or "small amount”) "at a time with” (select one of the following,

appropriate: "applicator" “brush") "to sufficiently cover each wart. Let dry. Repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks."

(3) For products containing salicylic acid identified in $358.110(c). “Wash affected area. (Optional: “May soak wart in warm water for 5 minutes.") Dry area thoroughly. Gently smooth wart surface with emery file supplied.” (If appropriate: “Cut plaster to fit wart."') “Apply a drop of warm water to the wart, keeping the surrounding skin dry. Apply medicated plaster at bedtime and leave in place for at least 8 hours. In the morning, remove plaster and discard. Repeat procedure every 24 hours as needed (until wart is removed) for up to 12 weeks."

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

(f) The phrase "or podiatrist” may be used in addition to the word “doctor's in any of the labeling statements in this section when a product is labeled with the indication identified in $358.150(b)(2).

(55 FR 33255, Aug. 14, 1990; 55 FR 37403, Sept. 11, 1990, as amended at 57 FR 44495, Sept. 28, 1992; 59 FR 60317, Nov. 23, 1994)

Subparts C-E [Reserved]

Subpart F-Corn and Callus

Remover Drug Products

SOURCE: 55 FR 33261, Aug. 14, 1990, unless otherwise noted.

8358.501 Scope.

(a) An over-the-counter corn and callus remover drug product in a form suitable for topical application is generally recognized as safe and effective

and is not misbranded if it meets each of the conditions in this subpart and each of the general conditions established in 8330.1 of this chapter.

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

$ 358.503 Definitions.

As used in this subpart:

(a) Corn and callus remover drug product. A topical agent used for the removal of corns and calluses.

(b) Collodion-like vehicle. A solution containing pyroxylin (nitrocellulose) in an appropriate nonaqueous solvent that leaves a transparent cohesive film when applied to the skin in a thin layer.

(c) Plaster vehicle. A fabric, plastic, or other suitable backing material in which medication is usually incorporated for topical application to the skin.

$ 358.510 Corn and callus remover ac

tive ingredients. The product consists of any of the following active ingredients within the specified concentrations and in the dosage form established for each ingredient.

(a) Salicylic acid 12 to 40 percent in a plaster vehicle.

(b) Salicylic acid 12 to 17.6 percent in a collodion-like vehicle.

ing 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 the removal of corns and calluses.'

(2) In addition to the information identified in paragraph (b)(1) of this section, the labeling of the product may contain the following statement: “Relieves pain by removing corns and calluses."

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

(1) For products containing any ingredient identified in § 358.510. (i) “For external use only."

(ii) "Do not use this product on irritated skin, on any area that is infected or reddened, if you are a diabetic, or if you have poor blood circulation.

(iii) “If discomfort persists, see your doctor or podiatrist.'

(2) For any product formulated in a hammable vehicle. (1) The labeling should contain an appropriate flammability signal word, e.g., "extremely flammable," "flammable,”

“flammable," "combustible," consistent with 16 CFR 1500.3(b)(10).

(ii) “Keep away from fire or flame."

(3) For any product formulated in a volatile vehicle. “Cap bottle tightly and store at room temperature away from heat."

(4) For any product formulated in a collodion-like vehicle. (i) "If product gets into the eye, flush with water for 15 minutes."

(ii) “Avoid inhaling vapors."

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

(1) For products containing salicylic acid identified in $ 358.510(a). "Wash affected area and dry thoroughly.” (If appropriate: "Cut plaster to fit corn/callus.") "Apply medicated plaster. After 48 hours remove the medicated plaster. Repeat this procedure every 48 hours as needed for up to 14 days (until corn/callus is removed).” (Optional: “May soak corn/callus in warm water for 5 minutes to assist in removal.")

8 358.550 Labeling of corn and callus

remover 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 a "corn and callus remover."

(b) Indications. The labeling of the product states, under the heading “Indications," the phrase listed in paragraph (b)(1) of this section and may contain the additional phrase listed in paragraph (b)(2) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established in paragraph (b) of this section, 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) relat

(2) For products containing salicylic acid identified in $ 358.510(6). Wash affected area and dry thoroughly. Apply" (select one of the following, as appropriate: “one drop" or "small amount") "at a time with” (select one of the following, as appropriate: “applicator” or “brush") "to sufficiently cover each corn/callus. Let dry. Repeat this procedure once or twice daily as needed for up to 14 days (until corn/callus is removed).” (Optional: “May soak corn callus in warm water for 5 minutes to assist in removal.")

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

(55 FR 33261, Aug. 14, 1990, as amended at 57 FR 44494, Sept. 28, 1992)

Subpart G-Pediculicide Drug

Products

SOURCE: 58 FR 65455, Dec. 14, 1993, unless otherwise noted.

$ 358.601 Scope.

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

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

the product as a “pediculicide (lice treatment)" or "lice treatment."

(b) Indications. The labeling of the product states, under the heading “Indications," the following: "For the treatment of head, pubic (crab), and body lice." 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 $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.

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

(1) “Use with caution on persons allergic to ragweed."

(2) “For external use only. Do not use near the eyes or permit contact with mucous membranes, such as inside the nose, mouth, or vagina, as irritation may occur. Keep out of eyes when rinsing hair. Adults and children: Close eyes tightly and do not open eyes until product is rinsed out. Also, protect children's eyes with washcloth, towel or other suitable material, or by a similar method. If product gets into the

eyes, immediately flush with water.

(3) "If skin irritation or infection is present or develops, discontinue use and consult a doctor. Consult a doctor if infestation of eyebrows or eyelashes occurs."

(4) The word 'physician" may be substituted for the word “doctor” in any of the warning statements in this paragraph.

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

(1) For all products. "Important: Read warnings before using." [sentence in all capital letters and boldface type]

(2) For nonshampoo products. “Apply to affected area until all the hair is thoroughly wet with product. Allow

$ 358.603 Definition.

As used in this subpart:

Pediculicide drug product. A drug product for the treatment of head, pubic (crab), and body lice.

$ 358.610 Pediculicide active ingredi.

ents.

The active ingredients of the product consist of the combination of pyrethrum extract (0.17 to 0.33 percent) with piperonyl butoxide (2 to 4 percent) in a nonaerosol dosage formulation.

8358.650 Labeling of pediculicide drug

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

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