INGREDIENT

Salicylic acid in scalp care

Folivis lists salicylic acid in RESET. FDA's OTC dandruff monograph includes salicylic acid at specified drug concentrations, but Folivis does not use ingredient presence alone as proof that RESET is an OTC dandruff drug or a hair-loss treatment.

Topic: Ingredients, Explained

What it is

Why it is used

Salicylic acid is listed in the current RESET formula.

What the evidence says

Ingredient presence is a formula fact — Salicylic acid is listed in the current RESET formula.

Drug claims have specific conditions — FDA's dandruff monograph specifies salicylic-acid drug concentrations for qualifying OTC dandruff products.

Do not turn that into a Folivis drug claim — Without matching the monograph conditions and intended-use requirements, ingredient presence alone does not establish an OTC dandruff-treatment claim.

EVIDENCE CHAIN

Claims stay connected to their evidence.

REGULATORY

A product's intended use and claims matter when distinguishing a cosmetic from a drug.

Population / context: U.S. personal-care product labeling

The format or ingredient list alone does not establish approval, safety or effectiveness.

REGULATORY

Is It a Cosmetic, a Drug, or Both?

Folivis uses this source in relation to the following reviewed statement(s):

A product's intended use and claims matter when distinguishing a cosmetic from a drug.

The format or ingredient list alone does not establish approval, safety or effectiveness.

U.S. Food and Drug Administration ↗

IMPORTANT LIMITS

The FDA monograph applies to OTC drug products that meet its conditions. It must not be used to imply that Folivis RESET meets those drug conditions or has an established dandruff-treatment claim.

The format or ingredient list alone does not establish approval, safety or effectiveness.

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