The antiperspirant monograph provides very specific labeling requirements for an antiperspirant drug product as follows:
1. A statement that the product be identified as an antiperspirant and that the product contains a drug identified by its established name, if a drug is present.
2. Under a heading titled “uses” the following language may be used by selecting one of the following phrases: “decreases,” “lessens,” or reduces underarm: “dampness,” “perspiration,” “sweat,” “sweating,” or “wetness.” Other language can be appended to the phrase if it is truthful and not a misleading statement describing an established use as follows: “decreases, lessens or reduces” underarm “dampness, perspiration, sweat, sweating or wetness due to stress.” For products that demonstrate the minimum standard of 20% sweat reduction over a 24-hour period the label may state either “all day protection,” “lasts all day,” “lasts 24 hours,” or “24-hour protection.”
For products that demonstrate extra effectiveness of 30% sweat reduction the label may state “extra effective.” In addition for products that demonstrate the extra effective reduction over a 24-hour period the language for the standard reduction may be used or combined with any one of these statements: “24-hour extra effective protection,” “all day extra effective protection,” “extra effective protection lasts 24 hours,” or “extra effective protection lasts all day.”
The product label must also contain the following items listed under “Warnings:” “Do not use on broken skin.”
“Stop use if rash or irritation occurs.”
“Ask a doctor before use if you have kidney disease.”
If the product is aerosolized:
“When using this product keep away from face and mouth to avoid breathing it.” The label must also contain the following under the heading of “Directions:” “Apply to underarms only” (4).
The regulatory agencies in other countries have not been as specific in as many details as the FDA.