Active Ingredient
Salicylic Acid 2%
Salicylic Acid Cream
FDA Label NDC 80861-117
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Acne Free, Llc for the product Salicylic Acid (NDC 80861-117). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, when using this product, keep out of reach of children, avoid contact with eyes, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne treatment
Use
Use for the treatment of acne
Warnings
For external use only
When Using This Product
When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Avoid Contact With Eyes
Avoid contact with the eyes. It contact occurs, ush thoroughly with water.
Directions
wet hands and face • squeeze scrub into hands and rub together • apply to face and massage gently, avoiding contact with eyes. If contact occurs, rinse thoroughly with water. • rinse face
Inactive Ingredients
water, cocamidopropyl betaine, sodium cocoyl isethionate, glycerin, coco-glucoside, hydrogenated castor oil, acrylates/C10-30 alkyl acrylate crosspolymer, sodium hydroxide, sodium benzoate, avena sativa (oat) kernel oil, guar hydroypropyltrimonium chloride, hydrogenated jojoba oil, zingiber of cinale (ginger) root juice, charcoal powder, iron oxides (CI 77499)
Questions Or Comments?
1-888-768-2913
* Please review the disclaimer below.
