Otc - Active Ingredient
Sulfur 3.5%
Sulfur Acne Treatment Cream
FDA Label NDC 80861-116
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 for the product Sulfur Acne Treatment (NDC 80861-116). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - 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
Otc - Purpose
Acne Treatment
Indications & Usage
for the treatment of acne
Warnings
for external use only
Otc - Do Not Use
Do not use on • broken skin • large areas of the skin
Otc - When Using
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. • apply only to areas with acne
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right way.
Directions
Directions • gently massage into clean wet skin for two to three minutes • leave on for an additional 10 minutes, until dry • rinse off with warm water and pat dry • if you experience a tightening and cooling effect that you find too strong, rinse off the mask immediately if uncomfortable • use 2-3 times per week, or as desired • avoid the eye and lip areas
Other Information
Other information • store at 59˚–95˚ F (15˚–35˚ C) • avoid product contact with silver jewelry, which may be discolored by this product
Inactive Ingredient
Inactive ingredients water, kaolin, bentonite, glycerin, magnesium aluminum silicate, acacia senegal gum, sodium bicarbonate, sodium ascorbyl phosphate, sodium cocoyl isethionate, phenoxyethanol, xanthan gum, caprylyl glycol, tetrasodium EDTA, ethylhexylglycerin, hexylene glycol, coconut acid, avena sativa (oat) bran extract, menthyl lactate, zinc PCA, magnesium aspartate, zinc gluconate, copper gluconate
Questions Or Comments?
Questions or comments? 1-888-768-2913
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Acne Clearing Mask (Acneclearingmaskproductlabel)
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