Label: BREAKOUT CLEARING DAYTIME TREATMENT- benzoyl peroxide 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 November 24, 2015

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzoyl Peroxide (2.5%).

  • Purpose

    Acne Treatment.

  • Use

    • for the treatment of acne
  • Warnings

    For external use only

    Do not use

    • in or near eyes
    • on broken skin
    • on lips or large areas of the body
    • if you have very sensitive skin
    • if you are sensitive to benzoyl peroxide

    When using this product

    • apply to affected areas only
    • avoid unnecessary sun exposure and use sunscreen
    • This product may bleach hair or dyed fabrics.
    • Using other topical acne products at the same time or immediately following the use of this product may increase dryness or irritation of the skin. Only one product should be used unless directed by a physican.

    Stop use and ask a physician

    • if too much skin irritation or sensitivity develops or increases

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Cleanse the skin thoroughly before applying.
    • Cover the affected area with a thin layer 1 to 3 times a day.
    • Because too much drying of the skin may occur, start with one application daily, and then gradually increase to 2 or 3 times daily if needed or as directed by a physician.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
    • If going outside use a sunscreen. Allow Daytime Treatment to dry then follow directions of the sunscreen labeling.
  • Inactive ingredients

    Water/Aqua/Eau, Niacinamide, Glycerin, Dimethicone, Helianthus Annuus (Sunflower) Seed Oil, Cucumis Sativus (Cucumber) Fruit Extract, Lavandula Angustifolia (Lavender) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Boerhavia Diffusa Root Extract, Sodium Acrylates Copolymer, Lecithin, Galactoarabinan, Glyceryl Polyacrylate, Polyisobutene, Dipotassium Glycyrrhizate, Butylene Glycol, Xanthan Gum, Polyacrylate-13, 1,2-Hexanediol, Polysorbate 20, Disodium EDTA, Citric Acid, Ethylhexylglycerin, Phenoxyethanol.

  • Other information

    • Protect this product from excessive heat and direct sun.
  • Questions or comments

    Call toll free 1-800-831-5150 in the US

  • PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

    dermalogica®
    clear

    2.5%
    benzoyl
    peroxide

    Breakout Clearing
    Daytime
    Treatment

    2.0 US Fl. Oz. / 60 mL e

    Principal Display Panel - 60 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    BREAKOUT CLEARING DAYTIME TREATMENT 
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Niacinamide (UNII: 25X51I8RD4)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Cucumber (UNII: YY7C30VXJT)  
    Lavandula Angustifolia Flowering Top (UNII: 9YT4B71U8P)  
    Rosemary (UNII: IJ67X351P9)  
    Boerhavia Diffusa Root (UNII: KR0SR09KYL)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Egg Phospholipids (UNII: 1Z74184RGV)  
    Galactoarabinan (UNII: SL4SX1O487)  
    Polyisobutylene (1300 MW) (UNII: 241BN7J12Y)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-160-021 in 1 CARTON
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68479-160-0114 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:68479-160-002 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D06/04/2013
    Labeler - Dermalogica, Inc. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    PakLab790530976MANUFACTURE(68479-160)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes161104729MANUFACTURE(68479-160)
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!