Label: BREAKOUT CLEARING BOOSTER- salicylic acid liquid

  • NDC Code(s): 68479-772-00, 68479-772-01, 68479-772-02, 68479-772-05
  • Packager: Dermalogica, 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 July 1, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Salicylic Acid (2.0%)

    Purpose

    Acne Treatment

  • Use

    • For the treatment of acne
  • Warnings

    For external use only

    Do not use

    • In or near eyes. If contact occurs, flush thoroughly with water.

    When using this product

    • Apply to affected areas only.
    • Skin irritation and dryness are 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.

    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

    • Protect this product from excessive heat and direct sun.
  • Inactive ingredients

    Water/Aqua/Eau, PPG-15 Stearyl Ether, Butylene Glycol, Glycerin, Isopropyl Lauroyl Sarcosinate, Niacinamide, Cetearyl Glucoside, 1,2-Hexanediol, Polysorbate 20, Hydroxyacetophenone, Chlorella Vulgaris Extract, Terpineol, Thymol, Chondrus Crispus (Carrageenan) Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Lactic Acid, Sodium Hyaluronate, Dimethicone, Xanthan Gum, Sclerotium Gum, Lecithin, Pullulan, Propanediol, Tetrasodium Glutamate Diacetate, Silica, Sodium Hydroxide, Sodium Citrate, Limonene.

  • Questions or comments

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

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    clears breakout
    causing bacteria in
    15 minutes

    breakout clearing
    booster

    dermatologica
    clear start

    1.0 US FL OZ / 30 mL e

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    BREAKOUT CLEARING BOOSTER 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-772
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Lauroyl Sarcosinate (UNII: LYR06W430J)  
    Niacinamide (UNII: 25X51I8RD4)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Hydroxyacetophenone (UNII: G1L3HT4CMH)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Propanediol (UNII: 5965N8W85T)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Pullulan (UNII: 8ZQ0AYU1TT)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)  
    Terpineol (UNII: R53Q4ZWC99)  
    Thymol (UNII: 3J50XA376E)  
    Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    LACTIC ACID, DL- (UNII: 3B8D35Y7S4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-772-021 in 1 CARTON04/09/2021
    130 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    2NDC:68479-772-0110 mL in 1 BOTTLE; Type 0: Not a Combination Product04/09/2021
    3NDC:68479-772-054 mL in 1 TUBE; Type 0: Not a Combination Product04/09/2021
    4NDC:68479-772-002 mL in 1 POUCH; Type 0: Not a Combination Product04/09/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D04/09/2021
    Labeler - Dermalogica, Inc. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway052400223MANUFACTURE(68479-772)
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