Antiperspirant Drugs
The Food and Drug Administration (FDA) has established an OTC monograph specifically for antiperspirant drugs. This monograph outlines the ingredients and labeling requirements to ensure these products are safe and effective. The allowed active ingredients are various aluminum salts, with concentration limits. Additionally, the monograph dictates what information must be included on the label, such as the product's identity as an antiperspirant and its active ingredients. This regulation helps ensure that antiperspirants sold over-the-counter meet specific quality and safety standards.
| Active Ingredients | OTC Monograph Number |
|---|---|
| (a) Aluminum chloride up to 15 percent, calculated on the hexahydrate form, in an aqueous solution nonaerosol dosage form | M019.10 (Part 350) |
| (b) Aluminum chlorohydrate up to 25 percent | M019.10 (Part 350) |
| (c) Aluminum chlorohydrex polyethylene glycol up to 25 percent | M019.10 (Part 350) |
| (d) Aluminum chlorohydrex propylene glycol up to 25 percent | M019.10 (Part 350) |
| (e) Aluminum dichlorohydrate up to 25 percent | M019.10 (Part 350) |
| (f) Aluminum dichlorohydrex polyethylene glycol up to 25 percent | M019.10 (Part 350) |
| (g) Aluminum dichlorohydrex propylene glycol up to 25 percent | M019.10 (Part 350) |
| (h) Aluminum sesquichlorohydrate up to 25 percent | M019.10 (Part 350) |
| (i) Aluminum sesquichlorohydrex polyethylene glycol up to 25 percent | M019.10 (Part 350) |
| (j) Aluminum sesquichlorohydrex propylene glycol up to 25 percent | M019.10 (Part 350) |
| (k) Aluminum zirconium octachlorohydrate up to 20 percent | M019.10 (Part 350) |
| (l) Aluminum zirconium octachlorohydrex gly up to 20 percent | M019.10 (Part 350) |
| (m) Aluminum zirconium pentachlorohydrate up to 20 percent | M019.10 (Part 350) |
| (n) Aluminum zirconium pentachlorohydrex gly up to 20 percent | M019.10 (Part 350) |
| (o) Aluminum zirconium tetrachlorohydrate up to 20 percent | M019.10 (Part 350) |
| (p) Aluminum zirconium tetrachlorohydrex gly up to 20 percent | M019.10 (Part 350) |
| (q) Aluminum zirconium trichlorohydrate up to 20 percent | M019.10 (Part 350) |
| (r) Aluminum zirconium trichlorohydrex gly up to 20 percent | M019.10 (Part 350) |
These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.
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