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  1. Guidance, Compliance, & Regulatory Information

OTC Warning Letters

OTC Warning Letters

2000-2011 Warning Letters are archived. To view them, please see the FDA Archive

This is not an inclusive list and is not meant to reflect Agency priorities

Anorectals

Antacids 

Antimalarials/Leg Cramps/Quinine 

Anthelmintics 

Antifungals

Aphrodisiacs 

Cold and Cough

External Analgesics

Internal Analgesics/Antipyretic/Antirheumatic 

Male Genital Desensitizers

Nicotine Products

Ophthalmics

Pediculicides

Skin Protectants/Skin Barriers

Sleep Aids/Sedatives/Stimulants

Stimulants

Sunscreens

Topical Antibiotics

Topical Antimicrobials

Topical Hormone Replacement

Vaginal Contraceptives

Wart Removers