Label: ACNE DEFENSE FACE WASH- salicylic acid 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 January 6, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 2.0%

  • Purpose

    Acne Medication

  • Use

    For the treatment of acne.

  • Warnings

    For external use only.

    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.

    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 and rinse thoroughly 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

    Aqua, Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Aloe Barbadensis Leaf Juice1, Glycerin, Niacinamide, Cucumis Sativus (Cucumber) Fruit Extract1, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract1, Chamomilla Recutita (Matricaria) Flower Extract1, Camellia Sinensis (White Tea) Leaf Extract1, Arnica Montana Flower Extract1, Salvia Officinalis (Sage) Oil, Mentha Piperita (Peppermint) Oil, Panthenol, Allantoin, Potassium Sorbate, Sodium Benzoate, Sodium PCA, Ethylhexylglycerin, Parfum2.

    1
    certified organic
    2
    our scent blend with natural and/or essential oils
  • Questions or comments?

    Call toll free 1-888-322-2466

    Pacifica Beauty LLC Portland, Oregon

  • PRINCIPAL DISPLAY PANEL - 172 ML Bottle Label

    PACIFICA®

    ACNE
    DEFENSE
    FACE WASH

    deep clean
    skin daily
    +
    maximum strength
    2% salicylic acid
    acne medication
    +
    cucumber
    niacinamide
    aloe & mint
    acne prone & oily skin

    100% VEGAN
    CRUELTY-FREE

    5.8 FL OZ • 172 ML

    PRINCIPAL DISPLAY PANEL - 172 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    ACNE DEFENSE FACE WASH 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61197-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Glycerin (UNII: PDC6A3C0OX)  
    Niacinamide (UNII: 25X51I8RD4)  
    Cucumber (UNII: YY7C30VXJT)  
    Lavandula angustifolia subsp. Angustifolia flowering top (UNII: 9YT4B71U8P)  
    Chamomile (UNII: FGL3685T2X)  
    White Tea (UNII: O0M3396E09)  
    Arnica Montana Flower (UNII: OZ0E5Y15PZ)  
    Sage Oil (UNII: U27K0H1H2O)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Panthenol (UNII: WV9CM0O67Z)  
    Allantoin (UNII: 344S277G0Z)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61197-100-00172 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D02/01/2020
    Labeler - Pacifica Beauty LLC. (058549421)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Deep Inc.189788201MANUFACTURE(61197-100)
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