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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2013]
[CITE: 21CFR740.12]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER G--COSMETICS

PART 740 -- COSMETIC PRODUCT WARNING STATEMENTS

Subpart B--Warning Statements

Sec. 740.12 Feminine deodorant sprays.

(a) For the purpose of this section, the term "feminine deodorant spray" means any spray deodorant product whose labeling represents or suggests that the product is for use in the female genital area or for use all over the body.

(b) The label of a feminine deodorant spray shall bear the following statement:

Caution --For external use only. Spray at least 8 inches from skin. Do not apply to broken, irritated, or itching skin. Persistent, unusual odor or discharge may indicate conditions for which a physician should be consulted. Discontinue use immediately if rash, irritation, or discomfort develops.

The sentence "Spray at least 8 inches from skin" need not be included in the cautionary statement for products whose expelled contents do not contain a liquified gas propellant such as a halocarbon or hydrocarbon propellant.

(c) Use of the word "hygiene" or "hygienic" or a similar word or words renders any such product misbranded under section 602(a) of the Federal Food, Drug, and Cosmetic Act. The use of any word or words which represent or suggest that such products have a medical usefulness renders such products misbranded under section 502(a) of the Act and illegal new drugs marketed in violation of section 505 of the Act.

[40 FR 8929, Mar. 3, 1975]

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