Label: MALIN AND GOETZ ACNE TREATMENT- sulfur cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 29, 2022

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  • ACTIVE INGREDIENT

    Active ingredient purpose

    Sulfur 10% Acne Treatment

  • PURPOSE

    Uses

    • treats acne
    • dries up acne pimples
    • helps prevent acne pimples
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • INDICATIONS & USAGE

    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.

  • WARNINGS

    Warnings

    For External Use only

    When using this product

    • apply only to areas with acne

    Do not use

    • on broken skin
    • or large areas of skin
  • DOSAGE & ADMINISTRATION

    Directions

    • Clean skin thoroughly before applying this product
    • cover the affected area with a thin layer once a day
    • if bothersome dryness or peeling occurs, reduce application to once every other day
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Isopropyl Alcohol, Water, Zinc Oxide, Camphor, Salicylic Acid, Magnesium Aluminum Silicate

  • PRINCIPAL DISPLAY PANEL

    (Malin + Goetz)

    acne treatment nighttime

    10% Sulfur lotion. Overnight Treatment

    Advanced Technology

    .5 fl. oz. 14ml

    acne night treat carton

    acne treat night jar

  • INGREDIENTS AND APPEARANCE
    MALIN AND GOETZ  ACNE TREATMENT
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53634-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53634-010-021 in 1 CARTON11/05/2012
    1NDC:53634-010-0114.75 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00611/05/2012
    Labeler - Malin and Goetz Inc (138615930)
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