Active Ingredient
Sulfur 3.0%
Sulfur Cream
FDA Label NDC 67923-106
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vege Labs Llc for the product Sulfur (NDC 67923-106). 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, uses, warnings, do not use on, 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
Uses
For the management of acne
Warnings
For external use only
Do Not Use On
Broken skin, Large areas of the skin
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
Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a poison control center right away
Directions
Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer. Leave on for 10-15 minutes, rinse thoroughly, and pat dry. Because excessive drying of the skin may occur, start with one application weekly then gradually increase to two or three times weekly if needed or as directed by a doctor. If bothersome dryness or peeing occurs, reduce application to once a week or every other week.
Inactive Ingredients
Water, Illite, Glycerin, Propanediol, Magnesium Aluminum Silicate, Caolin, Ethyl Linoleate, Glyceryl Stearate, Cetearyl Alcohol, Ceteareth-20, PEG-100 Stearate, Microcrystalline Wax, Potassium Azeloyl Diglycinate, Morinda Citrifolia Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Menthol, Camellia Sinensis Leaf Extract, Pyrus Malus (Apple) Fruit Extract, Lens Esculenta (Lentil) Fruit Extract, Sodium Lactate, Sodium PCA, Citrus Aurantium Bernamia (Bergamot) Peel Oil, Polyisobutene, Caprylyl/Capryl Glucoside, Sorbitan Oleat, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Caprylyl Glycol, Ethylhexylglycerin, Potassium Chloride, Citric Acid, Disodium EDTA, Xanthan Gum, Chlorphenesin, Potassium Sorbate, Sodium Benzoate, Phenoxyethanol, Chromium Oxide Greens
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