As with all treatment programs, the key to achieving maximum benefit is compliance. Antiperspirant products can require up to 10 consecutive days to reach maximum efficacy and benefits can be completely eliminated within 14 days of treatment termination. Barriers to compliance are typically associated with products’ aesthetics rather than skin irritation. Refer to Table 3 […]

Approved Active Ingredients The final OTC antiperspirant monograph itemized the 18 active ingredients that are approved for use in antiperspirant products in the U. S. Table 2 shows each of the approved Table 2 Antiperspirant Active Ingredients Active ingredient Concentration Dosage form Aluminum chloride Up to 15% (calculated on hexahydrate form) Only aqueous solution (must […]

Historically, there has been some confusion among the public when distinguishing between the benefits provided by commercial antiperspirant and deodorant products (8). While antiperspirants are designed to reduce both axillary sweating and malodor, deodorants provide only malodor control. The most effective deodorants are typically glycol-based products containing odor-masking fragrances. The use of a glycol base […]

Antiperspirant products are relatively unusual drug formulations. Unlike most drugs, their mechanism of action is physical rather than pharmacological. Figure 1 illustrates how the antiperspirant actives form a shallow plug near the opening of an eccrine sweat duct on the skin surface (7). These blockages prevent the eccrine excretion from reaching the skin surface in […]

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 […]

In the U. S. the FDA has included in the OTC Antiperspirant Final Monograph guidelines that the manufacturer may use in testing for effectiveness. The agency does not require that these guidelines be used but requests that alternate methods and statistical evaluations are subject to FDA approval (4). The FDA has established in the monograph […]

In the European Common Market antiperspirants are considered to be cosmetic products and are therefore subject to the European Cosmetic Directive. The definition of a cosmetic product is “any substance or preparation intended to come in contact with the various surface areas of the body (epidermis, hair, and capillaries, nails, lips, and external genital organs) […]

The regulatory status of antiperspirants is somewhat different in various regions of the world market place. United States In the United States an antiperspirant is categorized as an over-the-counter (OTC) drug product and therefore subject to regulations by the Food and Drug Administration (FDA). In 1972 the FDA announced a proposed review of the safety, […]

Definition An antiperspirant, as defined by the Department of Health and Human Services in the final antiperspirant monograph published in 2003, reads as follows: “A drug product applied topically that reduces the production of perspiration (sweat) at that site” (4). There has always been some confusion in the industry that consumers do not always relate […]