FDA WARNING_LETTER - Dolgencorp Inc

The FDA issued a Warning Letter to Dolgencorp, Inc. regarding their drug product, "Rexall Earache Relief Drops," following a review of its labeling and marketing information. The product is deemed in violation of the Federal Food, Drug, and Cosmetic Act (the Act), specifically misbranded under Sections 502 and 503, and in violation of Section 301.

The product's labeling, including its name, website claims, and statements about "Mercurius Solubilis" and pain relief, establish it as a drug intended for disease treatment or to affect body function. Despite being marketed as an over-the-counter (OTC) drug, "Rexall Earache Relief Drops" is classified as a prescription drug under Section 503(b)(1) of the Act. This is because ear pain requires diagnosis and treatment by a physician, and is not a recognized OTC indication in the final monograph for topical otic drug products (21 CFR 344) or any approved OTC new drug application.

Consequently, the product is misbranded under Section 503(b)(4) for failing to bear the "Rx only" symbol. It is also misbranded under Section 502(f)(1) due to inadequate directions for use, as the indication for ear pain is not appropriate for OTC use. Furthermore, the labeling is considered false or misleading under Section 502(a)