Label: SULFUR ACNE TREATMENT- sulfur cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 1, 2024

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  • ACTIVE INGREDIENT

    Sulfur 3.5%

  • PURPOSE

    Acne Treatment

  • INDICATIONS & USAGE

    for the treatment 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 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

  • PRINCIPAL DISPLAY PANEL

    Acne Clearing Mask

  • INGREDIENTS AND APPEARANCE
    SULFUR ACNE TREATMENT 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80861-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR0.035 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80861-116-011 g in 1 TUBE; Type 0: Not a Combination Product02/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00602/02/2024
    Labeler - Acne Free (122237140)
    Establishment
    NameAddressID/FEIBusiness Operations
    Paklab177711082manufacture(80861-116)
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