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Guidance on OTC Skin Product Labeling

08/04/2008

Federal Register Notice: FDA is making available a draft guidance, Labeling OTC Skin Protectant Drug Products. An OTC skin protectant active ingredient can be combined with another OTC skin protectant active ingredient or OTC external analgesic, first aid antiseptic, or sunscreen active ingredients. Each of these combinations has specific labeling requirements. This guidance aims to clarify the permitted combinations of active ingredients along with the corresponding required labeling. To download this guidance, click here. To view this notice, click here.

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