Label: PACIFICA BACNE WARRIOR- salicylic acid spray

  • 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 January 20, 2023

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  • Active ingredient Purpose

    Salicylic Acid 2.0% Acne Medication

  • Use

    For the treatment of acne.

  • Warnings

    For external use only. Flammable: Keep away from fire or flame.

  • INDICATIONS & USAGE

    When using this product: skin irritation and dryness is 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

    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. Sensitivity test for a new user. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

  • Inactive ingredients:

    Alcohol Denat., Aqua, Propanediol, Aloe Barbadensis Leaf Juice, Niacinamide, Cucumis Sativus (Cucumber) Fruit Extract, Glycerin, Lavandula Angustifolia (Lavender) Flower Extract, Salvia Officinalis (Sage) Leaf Extract, Mentha Pulegium Extract, Sodium Hydroxide, Parfum*. *our scent blend with natural and/or essential oils

  • Questions or comments?

    Call toll free 1-888-322-2466
    Pacifica Beauty LLC Portland, Oregon

  • Bacne Warrior Spray

    Bacne Warrior Spray Label

  • INGREDIENTS AND APPEARANCE
    PACIFICA BACNE WARRIOR 
    salicylic acid spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61197-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ALCOHOL (UNII: 3K9958V90M)  
    MENTHA PULEGIUM (UNII: 5Q6Y7K4846)  
    WATER (UNII: 059QF0KO0R)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    SAGE OIL (UNII: U27K0H1H2O)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61197-103-00177 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00601/20/2023
    Labeler - Pacifica Beauty, LLC (868275517)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell International Laboratories, Incorporated967781555manufacture(61197-103)
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