Label: QUICK DRY ACNE TREATMENT- sulfur lotion

  • 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 December 2, 2014

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  • ACTIVE INGREDIENTS:

    SULFUR- 10.0%

    ZINC OXIDE- 5.0%

  • PURPOSE:

    TREATS ACNE AND SHAVE BUMPS

  • USES:

    • DRIES UP EXCESS OIL
    • CLEARS UP ACNE AND SHAVING BUMPS
  • DIRECTIONS:

    USE EVENINGS. SHAKE TO ACTIVATE

    APPLY TO CLEAN SKIN AFTER SPF 30 IN AM OR ALOE MOISTURIZING CREAM IN PM

    APPLY DIRECTLY TO THE ACNE OR SHAVING BUMPS WITH A COTTON SWAB.

    ALLOW TO DRY FOR APPROXIMATELY 5-10 MINTUES AND LEAVE ON OVERNIGHT.

  • INACTIVE INGREDIENTS:

    ETHYL ALCOHOL, AQUA, SPIRAEA ULMARIA EXTRACT, CINNAMOMUM CAMPHORA OIL, MAGNESIUM ALUMINIUM SILICATE, PIGMENT YELLOW 42, PIGMENT BLACK11, PIGMENT RED 101, PEG-8 DIMETHICONE, GLYCERINE, OCTYLDODECANOL, RETINYL PALMITATE (VITAMIN A), TOCOPHERYL ACETATE (VITAMIN E),  ASCORBIC ACID (VITAMIN C), PYRIDOXINE HCL (VITAMIN B6), SILICA, SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA, CHOLECALCIFEROL

  • KEEP OUT OF REACH OF CHILDREN

    KEEP  OUT OF REACH OF CHILDREN.

  • WARNINGS

    FOR EXTERNAL USE ONLY

  • PRINCIPAL DISPLAY PANEL

    treatment-acne

  • INGREDIENTS AND APPEARANCE
    QUICK DRY ACNE TREATMENT 
    sulfur lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69299-101
    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
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    FILIPENDULA ULMARIA WHOLE (UNII: 3LH0M209LN)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69299-101-511 in 1 BOX
    1NDC:69299-101-1130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/17/2014
    Labeler - DR. THROWER'S SKINCARE, INC. (078711495)
    Registrant - DR. THROWER'S SKINCARE, INC. (078711495)
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