Label: ACNE VANISHING GEL- 10% WITH SULFUR- benzoyl peroxide, sulfur gel

  • NDC Code(s): 70367-003-01, 70367-003-04
  • Packager: Only Yourx, Inc.
  • 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 16, 2015

If you are a consumer or patient please visit this version.

  • WARNINGS

    WARNINGS: For External Use Only

  • ACTIVE INGREDIENT

    Active Ingredients:

    Benzoyl Peroxide 10%

    Sulfur 3%

  • INDICATIONS & USAGE

    Treats acne and helps prevent new blemishes from forming

    Kills acne bacteria

  • DO NOT USE

    Do Not Use: if you have very sensitive skin

    are sensitive to benzoyl peroxide or sulfur

  • WHEN USING

    When using this product

    avoid sun exposure and use sunscreen

    using other acne medications at the same time may cause excessive dryness or irritation of the skin

    may bleach hair and fabrics

    do not use in or near eyes, lips and mouth

  • ASK DOCTOR

    Consult a doctor if excessive irritation occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

  • DOSAGE & ADMINISTRATION

    Directions:

    cleanse skin thoroughly before applying

    cover entire affected area with thin layer 1 to 3 times daily

    if excessive dryness or irritation occurs, reduce application to once a day or every oter day
    if going outside, use a sunscreen

  • OTHER SAFETY INFORMATION

    Other information

    store at room temperature

    keep tightly closed

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, Ethoxydiglycol, Cetyl Octanoate, Glyceryl Stearate, APEG-100 Stearate, Glycerin, Propylene Glycol, Cetearyl Alcohol, Ceteareth-20, Polyacrylamide C13-14 Isoparaffin, Laureth-7, Dimethicone, Potassium Sorbate, Polysorbate 20, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Triethanolamine, Ethylhexylglycerin, Phenoxyethanol

  • PURPOSE

    To treat acne and reduce inflammation

  • PRINCIPAL DISPLAY PANEL

    Acne Vanishing Gel- 10% with Sulfur

  • INGREDIENTS AND APPEARANCE
    ACNE VANISHING GEL- 10% WITH SULFUR 
    benzoyl peroxide, sulfur gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70367-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETEARETH-22 (UNII: 28VZG1E234)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYL OCTACOSANOATE (UNII: O7F4812VDX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70367-003-0130 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    2NDC:70367-003-04120 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/28/2014
    Labeler - Only Yourx, Inc. (089207519)