Label: INTENSIVE FACE AND BODY ACNE TREATMENT- benzoyl peroxide gel

  • 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 July 11, 2014

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

View All Sections
  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    BENZYL PEROXIDE 10%

  • PURPOSE

    PURPOSE

    ACNE TREATMENT

  • INDICATIONS & USAGE

    USE

    FOR THE TREATMENT OF ACNE AND ACNE DARK AND RED MARKS.

  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

  • DO NOT USE

    DO NOT USE THIS MEDICATION IF YOU

    • HAVE VERY SENSITIVE SKIN OR IF YOU ARE SENSITIVE TO BENZOYL PEROXIDE.

  • ASK DOCTOR/PHARMACIST

    ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

  • WHEN USING

    When using this product

    • avoid unnecessary sun exposure and use a sunscreen.
    • avoid contact with eyes lips and mouth.
    • avoid contact with hair and dyed fabrics, which may be bleached by this product.
    • skin irritation may occur characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
  • STOP USE

    STOP USE AND ASK A DOCTOR IF IRRITATION BECOMES SEVERE.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DOSAGE & ADMINISTRATION

    Directions

    • wet area to be cleansed.
    • apply small amount to skin.
    • gently massage to create lather.
    • rinse thoroughly and pat dry.
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to twice daily if needed or directed by a doctor.
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outside, apply sunscreen after using this product.
  • OTHER SAFETY INFORMATION

    Other information

    • sensitivity test for new users: apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated.
    • avoid contact with hair and dyed fabrics, which may be bleached by this product.
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    Water, Sodium C14-16 Olefin Sulfonate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Aloe Barabadensis Leaf Extract, Sodium PCA, Allantoin, Panthenol, Phenoxyethanol, Methylisothiazolinone, Citrus Arantium Bergamia (Bergamot) Fruit Extract, Sodium Hydroxide

  • QUESTIONS

    QUESTIONS OR COMMENTS?

    1-877-445-4624

    MON-FRI 8AM - 5PM (PST)

  • PRINCIPAL DISPLAY PANEL

    DLSC_6ozIntensiveFaceBody_proofR1

  • INGREDIENTS AND APPEARANCE
    INTENSIVE FACE AND BODY ACNE TREATMENT 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58876-107
    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
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    BERGAMOT ORANGE (UNII: IET5D90X0D)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58876-107-36180 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/11/2014
    Labeler - DR LIN SKINCARE (622329980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Westwood Laboratories Inc.069926483manufacture(58876-107) , pack(58876-107)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!