Clarifast One Step Acne Treatment Cream
FDA Label NDC 82908-358
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vireo Systems, Inc. for the product Clarifast One Step Acne Treatment (NDC 82908-358). 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 drug facts, active ingredient, purpose, uses:, warnings:, when using this product:, keep out of reach of children., if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Salicylic Acid 0.5 %
Purpose
Acne Treatment
Uses:
• For the treatment of acne.
• Helps clear acne blemishes, pimples, and blackheads.
• Penetrates pores to reduce the number of acne blemishes, pimples and blackheads.
• Helps prevent new acne blemishes, pimples, and blackheads from forming.
• Helps prevent the development of new acne blemishes, pimples and blackheads.
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 at the same time. If irritation occurs, only use one topical acne medication at a time.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Directions:
• Apply to affected area and rub in lightly, one to two times daily (before bedtime or anytime during the day as desired). Allow 30 minutes to dry • If drying of the skin occurs, reduce application to once a day, every other day, or as directed by a doctor.
Other Information:
• Protect the product in this container from excessive heat and direct sun. Store at a controlled room temperature 20-25C (68-77F).
Inactive Ingredients:
Alpha-GEE®, Aloe Barbadensis Leaf Extract, Amezol®, Bellis Perennis Flower Extract, Cetyl Alcohol, Coconut Oil, Colloidal Oatmeal, Denatured Alcohol, Glyceryl Monostearate, Hamamelis Virginiana Extract 3X, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Polyethylene Glycol 400, Polyethylene Glycol 3350, Potassium Phosphate Dibasic, Propylene Glycol, Sulfur 1X, Zinc Oxide.
Package Labeling:
Label2 (Label2)
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