Label: SPECIAL CLEARING BOOSTER- benzoyl peroxide liquid

  • 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 23, 2015

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzoyl Peroxide (5.0%).

  • Purpose

    Acne treatment

  • Use

    • treats acne
  • Warnings

    For external use only

    Stop use and ask a Doctor 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.

    Do not use if you

    • have very sensative skin
    • are sensative to benzoyl peroxide
    • have broken skin

    When using this product,

    • Avoid unnecessary sun exposure and use a sunscreen.
    • Avoid contact with the eyes, lips, and mouth.
    • This product may bleach hair or dyed products.
    • Using other topical acne drugs at the same time or right after use of this product may increase dryness or irriatation of the skin.
  • 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 going outside, apply sunscreen after using this product. If irritation or sensativity develops, stop use of both products and ask a doctor.
  • Inactive ingredients

    Water/Aqua/Eau, PEG-8, Polysorbate 20, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Calendula Officinalis Flower Extract, Anthemis Nobilis Flower Extract, Tilia Cordata Flower Extract, Centaurea Cyanus Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Hypericum Perforatum Flower/Leaf/Stem Extract, Nasturtium Officinale Flower/Leaf Extract, Arctium Lappa Root Extract, Salvia Officinalis (Sage) Leaf Extract, Citrus Limon (Lemon) Fruit Extract, Hedera Helix (Ivy) Leaf/Stem Extract, Saponaria Officinalis Leaf/Root Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cyclodextrin, Hydrolyzed Algin, Silica, Zinc Sulfate, Benzophenone-4, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Butylene Glycol,Disodium EDTA, Caprylyl Glycol, Chlorphenesin, 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 - 30 mL Bottle Carton

    special
    clearing
    booster

    dermalogica®

    acne treatment

    mediBac clearing®

    1 US Fl. Oz.
    30 mL e

    Principal Display Panel - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SPECIAL CLEARING BOOSTER 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-503
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Lavandula Angustifolia Flowering Top (UNII: 9YT4B71U8P)  
    Calendula Officinalis Flower (UNII: P0M7O4Y7YD)  
    Chamaemelum Nobile Flower (UNII: O2T154T6OG)  
    Tilia Cordata Flower (UNII: CFN6G1F6YK)  
    Centaurea Cyanus Flower (UNII: QZ239038YC)  
    Chamomile (UNII: FGL3685T2X)  
    St. John's Wort (UNII: UFH8805FKA)  
    Nasturtium Officinale Flowering Top (UNII: W1N2U8I64G)  
    Arctium Lappa Root (UNII: 597E9BI3Z3)  
    Sage (UNII: 065C5D077J)  
    Lemon (UNII: 24RS0A988O)  
    Hedera Helix Leaf (UNII: ZP9XFG71A7)  
    Saponaria Officinalis Leaf (UNII: 3988313MM7)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Zinc Sulfate (UNII: 89DS0H96TB)  
    Sulisobenzone (UNII: 1W6L629B4K)  
    Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-503-021 in 1 CARTON
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68479-503-002 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D09/22/2011
    Labeler - Dermalogica, Inc. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    PakLab790530976MANUFACTURE(68479-503)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes161104729MANUFACTURE(68479-503)
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!