Sore Muscles
A product that is intended to relieve sore muscles is considered an analgesic (relieves pain) and is a drug.
If you make any claims that make the consumer think your product is intended to relieve sore muscles, then the product is a drug.
OTC External Analgesic Products
There are non-prescription topical analgesic products on the market that often look like cosmetics but are, in fact, over-the-counter drugs. Tiger Balm®, BenGay®, and Aspercreme® – all are actually made, labeled, and marketed as drugs. They meet the OTC Monograph for external analgesic drug products and use only approved ingredients, label claims, directions, and warning statements.
Reality vs. Regulation
The truth is that there are formulations based on natural substances that have traditionally been used to treat muscle pain (e.g., methyl salicylate, camphor, menthol, capsicum). In fact, Tiger Balm and BenGay use those ingredients.
It’s even possible that you could formulate a product containing those ingredients. However, since a sore muscle relief product is a drug, it would need to be manufactured in a registered drug manufacturing facility1 that follows the regulations covering the good manufacturing practices for drugs.2 In addition, most (or maybe all) states have drug manufacturing registration and licensing requirements.
1 21 CFR 330.1(b)
2 21 CFR 330.1(a)
