Label: SPOT CORRECTION- sulfur cream

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

Drug Label Information

Updated December 9, 2023

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  • Drug Facts

  • Active Ingredients 

    Colloidal Sulfur (3%)

    Purpose

    Acne treatment ointment

  • Uses

    • treats acne
    • helps prevent new pimples
    • clears up most acne pimples
  • Warnings

    For external use only

    Do not use on:

    • broken skin
    • large areas of the body

    When applying this product

    • apply only to areas with acne
    • rinse right away with water if it gets in eyes
    • 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.

    Stop use and ask a doctor if

    • skin irritation occurs or gets worse

    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 one to three times daily.
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • Other Information

    • store at controlled room temperature (59° - 86°F)
  • Inactive Ingredients

    4-t-Butylcyclohexanol, Acacia Senegal Gum, Arginine, Chondrus Crispus (Carrageenan), Citrus Grandis (Grapefruit) Peel Oil, Epilobium Angustifolium Flower/Leaf/Stem Extract, Lactic Acid, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Niacinamide, Pentylene Glycol, Rice Ferment (Sake) Filtrate, Sodium Hydroxide, Water (Aqua), Xanthan Gum

  • Questions or Comments?

    Call 1.800.932.9873

  • Package Labeling:

    Label3

  • INGREDIENTS AND APPEARANCE
    SPOT CORRECTION 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60934-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
    ACACIA (UNII: 5C5403N26O)  
    ARGININE (UNII: 94ZLA3W45F)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60934-002-011 in 1 BOX01/11/2017
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00601/11/2017
    Labeler - HydroPeptide LLC (006297465)
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