US FDA regulates Antiperspirants as OTC drugs because of their active ingredients block sweat glands. On the contrary deodorants are considered as cosmetics and mainly intended to mask the body odor.
As per FDA’s OTC Drug Monograph for antiperspirants (M019), these products must follow FDA regulations to follow safety and effectiveness.
Active Ingredients: Only certain aluminum-based compounds are permitted, such as aluminum chloride, aluminum chlorohydrate, and various aluminum zirconium salts, with concentration limits ranging from 15% to 25% depending on the compound.
Labeling: Principal display panel must be marked as “antiperspirants” and include specific usage directions, such as “apply to underarms only,” and warnings like “Do not use on broken skin” and “Stop use if rash or irritation occurs”
Finished dosage form of antiperspirants may vary in effectiveness because of difference in formulation. Manufacturers must follow FDA’s guidelines to make sure the effectiveness of the antiperspirant.
Since antiperspirants are considered as OTC drugs, the manufacturer must comply with all drug requirements such as establishment registration, drug listing and labeling requirements.
Also, the manufacturers and contract manufacturers must pay OMUFA fee every year.
Liberty Management Group , as a leading FDA consultant with provide assistance with drug establishment registration, drug listing and label review.
Sudha S
Regulatory Consultant
Email: office@libertymanagement.us