Otc - Active Ingredient
Active Ingredient Purpose
Salicylic Acid 2% Acne Treatment
Age Defying Blemish Treatment
FDA Label NDC 44717-148
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wasatch Product Development, Llc for the product Age Defying Blemish Treatment (NDC 44717-148). 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.
Label Section Quick Index
Otc - Purpose
Uses
For the treatment of acne
Dries up acne pimples
Helps prevent new acne pimples
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if irritation becomes severe.
Warnings
Warnings
For external use only
When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication. If irritation occurs, start with one application daily, then gradually increase to two or three times daily if needed or directed by a doctor.
If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Dosage & Administration
Directions
Clean the skin thoroughly before applying this product
Cover the entire affected area with a thin layer one to three times daily
Becuase excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three daily if needed or directed by a doctor.
Inactive Ingredient
Inactive ingredients SD Alcohol 40-B, Ethoxydiglycol, Water, Glycerin, Azelaic Acid, Nylon-10/10, Polyacrylate Crosspolymer-6, Propanediol, Betaine, PEG-8/SMDI Copolymer, PEG-12 Dimethicone, Palmitoyl Tripeptide-38, Lens Esculenta (Lentil) Seed Extract, Tetrahexyldecyl Ascorbate, Dipotassium Glycyrrhizinate, Hydroxypropyl Cyclodextrin, Triethanolamine, Fragrance
Package Label.Principal Display Panel
Clear
Age Defying Treatment
2% Salicylic Acid
Acne Treatment
4% Azelaic Acid
Skin Conditioner
30 ML/ 1 FL OZ
Carton Label (Carton)
Bottle Label (Bottle)
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