Label: DEFENSE ACNE CARE 2% SALICYLIC ACID- salicylic acid 2% soap

  • 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 December 5, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic acid 2%

  • PURPOSE

    Purpose

    Acne treatment

  • INDICATIONS & USAGE

    Uses

    • Treats acne.
    • Clears acne blemishes.
    • Helps prevent the development of new acne blemishes.
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product, skin irritation and dryness may occur if you use other topical acne medications at the same time. If irritation occurs, use only one 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Use hands to work into a lather.
    • Massage gently over wet skin.
    • Avoid contact with mouth and eyes.
    • Rinse thoroughly.
    • Use one to three times daily
    • If drying or peeling occurs, reduce usage to every other day.
    • After acne clears, continue using for preventative care.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Sodium Palmate, Sodium Palm Kernelate, Water, Sodium Gluconate, Eucalyptus Globulous Leaf Oil, Melaleuca Alternifolia (Tee Tree) Leaf Oil, Palm acid, Sodium chloride, Palm kernel acid, Avena Sativa (Oat) Kernel Flour, Titanium dioxide (CI77891), Chlorophyllin-Copper complex

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    D3 Development, Inc., Portland, ME 04101

    Made in the USA

  • PRINCIPAL DISPLAY PANEL

    DEFENSE ACNE CARE

    2% Salicylic Acid

    Tea Tree & Eucalyptus Essential Oils & Oatmeal

    Bar Soap

    Net Wt. 4.2 oz

    Carton

  • INGREDIENTS AND APPEARANCE
    DEFENSE ACNE CARE 2% SALICYLIC ACID 
    salicylic acid 2% soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70856-3582
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    OATMEAL (UNII: 8PI54V663Y)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    PALM ACID (UNII: B6G0Y5Z616)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)  
    PALM KERNEL ACID (UNII: 79P21R4317)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70856-3582-0119 g in 1 CARTON; Type 0: Not a Combination Product12/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/05/2019
    Labeler - Defense Soap LLC (780587353)