OTC Topical “Inactive” Ingredient Marketing Claims

This warning letter involves claims made about a topical OTC menthol product. OTC products must follow monographs. These are essentially recipe books that guide the ingredients, dosages, labeling, and claims that products are allowed to be made. This is how OTC products are permitted to make claims like “Arthritis Pain Relief” that are out of bounds for cosmetic and personal care products. 

To check if a product is an OTC topical product or not, check the label. If it lists “Drug Facts” and lists “Inactive Ingredients” it is labeled as an OTC drug. This is another reason why cosmetic product labels should not list ingredients in “active” or “inactive” sections, as this implies the product is a drug.

The product label has several violations cited in the warning letter. This shows that the product name is non-compliant and that therapeutic claims made about inactive ingredients are also not complaint. For all my regulatory nerds out there, here is a copy of the label I found online. 

👉 From warning letter. “Temporarily relieves minor pain associated with cramps” [from the product label]

👉 From warning letter. “Menstrual Cramp RELIEF CREAM” 

👉 From warning letter. “We believe in the power of plants and their therapeutic properties to offer solutions for menstrual discomforts.”

The moral of the story is that OTC topicals provide a gateway to making otherwise risky and forbidden claims, but the rules are narrow and don’t allow for extra marketing statements, which can increase the likelihood of regulatory action.

There are also drug-related GMP violations in this warning letter, which is worth reading. 

DATE ORIGINALLY POSTED: 4/16/25

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.