What Goes On My Over-The-Counter Drug Label?
Is your Cosmetic Product also an Over-The-Counter Drug? Click here for a definition. 

 A cosmetic product must be labeled according to cosmetic labeling regulations. See the Cosmetic Labeling Manual for guidance on cosmetic labeling and links to the regulations related to cosmetic labeling. 

OTC drugs must be labeled according to OTC drug regulations, including the "Drug Facts" labeling, as described in 21 CFR 201.66 

Combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling. For example, the drug ingredients must be listed alphabetically as "Active Ingredients," followed by cosmetic ingredients, listed in descending order of predominance as "Inactive Ingredients.“ 

Similar to the Nutrition Facts food label, the Drug Facts label uses simple language and an easy-to-read format to help people compare and select OTC medicines and follow dosage instructions. The following information must appear in this order: 
  • The product's active ingredients, including the amount in each dosage unit. 
  • The purpose of the product. 
  • The uses (indications) for the product. 
  • Specific warnings, including when the product should not be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist. This section also describes side effects that could occur and substances or activities to avoid. 
  • Dosage instructions--when, how, and how often to take the product. 
  • The product's inactive ingredients, important information to help consumers avoid ingredients that may cause an allergic reaction.

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