Otc - Active Ingredient
Active Ingredients Purpose
Salicylic Acid 2.0% Acne Treatment
The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Enterprises Ltd for the product Clear Acne Body (NDC 56152-5000). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients Purpose
Salicylic Acid 2.0% Acne Treatment
Uses
For the treatment of of Acne
Penetrates pores to eliminate most acne blemishes, blackheads, and whiteheads
Keep out of reach of children. If swallowed, get medical help or contact a Poison Crontrol Center right away.
Stop use and ask a doctor if skin irritation occurs or gets worse.
Warnings
For external use only.
Do not use
on broken skin
on large areas of the body
When using this product skin irritation and dryness is mroe likely to occur if you use another topical acne medication at the same time. If irritation, only use one topical acne medication at a time
Directions
After cleansing with Paula's Choice Clear Pore Normalizing Cleanser and exfoliating with Paula's Choice Clear Anti-Redness Exfoliating Solution.
Cover the entire affected area with a thin layer one to three times daily.
Hold container 4 to 6 inches from the skin to apply.
Do not spray directly into face. Spray on hands, then apply to face.
Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Inactive ingredients Water (Aqua), Dipropylene Glycol, Butylene Glycol, Polysorbate 20, Pentylene Glycol, Panthenol, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Glycyrrhiza Glabra (Licorice) Root Extract, Berberis Vulgaris (Barberry) Root Extract, Lauric Acid, Allantoin, Glycerin, PEG/PPG-17/6 Copolymer, Methyl Gluceth-20, Glycereth-26, Sodium Hydroxide, Sodium Metabisulfite, Disodium EDTA, Potassium Sorbate
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