Active Ingredient
Sulfur 3.5 percent
Sulfur Acne Foaming Cleanser Cream
FDA Label NDC 80861-113
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 Sulfur Acne Foaming Cleanser (NDC 80861-113). 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, warnings, do not use on, indications & usage, when using this product, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne Treatment
Warnings
For external use only
Do Not Use On
broken skin
large areas of skin
Indications & Usage
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
Directions
use every morning and evening
• apply a dime-size amount to damp skin and gently massage, avoiding the eye area
• rinse well
• use wash on entire affected area one to two times daily
• may be used on chest or back
Other Information
store at 59˚-95˚ F (15˚-35˚ C
Inactive Ingredients
water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium C14-16 olefin sulfonate, xanthan gum, acacia senegal gum, phenoxyethanol, caprylyl glycol, citric acid, citrus limon (lemon) peel oil, limonene, potassium hydroxide, ethylhexylglycerin, hexylene glycol, sodium hyaluronate, niacinamide, sodium sulfate, avena sativa (oat) bran extract, sodium lauroyl lactylate, glycolic acid, calendula officinalis flower extract, ceramide NP, ceramide AP, phytosphingosine, cholesterol, carbomer, ceramide EOP
Questions Or Comments?
1-888-768-2913
Package Label.Principal Display Panel
Sulfur Acne Foaming Cleanser (Labelartwork Af Sulfur Wash Primary V13 G3)
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