What is required by the FDA for OTC product labels?

• A. Purity or potency determinations
• B. Disease treatment claims
• C. Prices and vendors only
• D. Labels must contain important information about the product

Answer: (D)

The label for an OTC product must convey important information about the product so consumers can use it safely and effectively. This means the label should provide details that help someone decide if the product is appropriate for them and how to use it correctly. In practice, that includes what the product is and what it does, how much to take or apply, who should not use it (warnings and contraindications), and how to use it (directions). It also covers the active ingredients and their amounts, other information such as storage conditions and expiration date, and contact or questions information. The point is to give clear, essential guidance directly on the label, so users are informed at the moment of purchase and use. The other options miss the substance of labeling requirements: purity or potency are internal quality concerns, disease treatment claims require separate authorization, and simply listing prices and vendors does not provide the safety-focused information consumers need.