Label: SULFUR SPOT TREATMENT- sulfur gel

  • NDC Code(s): 70707-440-04, 70707-440-15
  • Packager: Face Reality, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • Drug Facts

  • Active ingredient

    Sulfur 6%

    Purpose

    Acne Treatment

  • Use

    for the treatment of acne

  • Warnings

    For external use only

    Do not use

    • on broken skin
    • on large areas of 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 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 room temperature. Keep away from heat or direct sunlight.

  • Inactive ingredients

    Aqua (Water), Butylene Glycol, Acacia Senegal Gum, Carbomer, Phenoxyethanol, Bisabolol (L-alpha), Allantoin, Benzyl Alcohol, Glycerin, Caprylhydroxamic Acid, Dextran, Sodium Hydroxide, Ethylhexylglycerin, Palmitoyl Tripeptide-8.

  • Questions or Comments?

    1-866-477-3077

  • Package Labeling:70707-440-15

    Tube

  • Package Labeling:70707-440-04

    Tube2

  • INGREDIENTS AND APPEARANCE
    SULFUR SPOT TREATMENT 
    sulfur gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70707-440
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ACACIA (UNII: 5C5403N26O)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PALMITOYL TRIPEPTIDE-8 (UNII: 55HZC7YQA7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70707-440-151 in 1 BOX01/08/2020
    144 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70707-440-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00601/08/2020
    Labeler - Face Reality, Inc (602958071)
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