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FDA
Overview
An OTC Drug is a safe and effective drug that can be used by the general public without a prescription. Antioxidants, sunscreens, dandruff shampoos, acne care products, and skin protectants with an astringent effect (products containing salicylic acid) are classified as OTC drugs in the US.
OTC registration requirements
In order to register as an OTC drug, the manufacturer must check whether the product contains active substances designated by the FDA.
If it does, the product must be registered as an “approved drug.”
If it does not, the product must be registered as an “unapproved drug” (also examine the possibility of registration).
The FDA classifies OTC drugs into roughly 80 product groups, and regulates the definition, efficacies, labeling, testing, and ingredients for each product.