Warning Required: Feminine Deodorant Spray
This article applies to feminine deodorant spray products sold in the United States.
Any spray product marketed as a “feminine deodorant spray” must have a warning statement.1
A feminine deodorant spray is any spray that states or implies that the product should be used in the female genital area or “all over” (including the genital area). It would include any spray “yoni” product. It does not matter what the ingredients are used in the spray.
The use of the terms “hygiene” or “hygienic” or similar words makes the product misbranded (and therefore illegal). A feminine deodorant spray is also misbranded if any word or words are used to suggest that the product has any medical usefulness (and also causes the product to become an unapproved new drug).2
Warning Statement
The warning statement must say:
CAUTION — FOR EXTERNAL USE ONLY. 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.
Spray with Propellant
If the contents are sprayed with a liquified gas propellant (such as a halocarbon or hydrocarbon propellant as in a pressurized spray container), the statement “Spray at least 8 inches from skin” must be included in the warning 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.
Warning Statement Requirements
The warning statement must be prominent and conspicuous, compared to other words or text on the label and be well contrasted with the background. The text must be at least 1/16 of an inch high (see Labeling: Measuring the Text Size).3 The warning statement does not need to be on the principal display panel; it may be on the back or side of the package so long as it is readily visible.
