Label: AXE ACNE CONTROL 2% SALICYLIC ACID- salicylic acid 2% soap

  • NDC Code(s): 64942-3785-8
  • Packager: CONOPCO, INC. D/B/A/ UNILEVER
  • 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 24, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic acid 2%

  • PURPOSE

    Purpose

    Acne treatment

  • Use

    Uses

    • For the treatment of acne
  • 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.

  • Directions

    Directions

    • Lather on body and face. Rinse. Feel great.
  • Inactive Ingredients

    Inactive ingredients

    Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Sodium Gluconate, Fragrance (Natural), Palm Acid, Sodium Chloride, Palm Kernel Acid, Petroselinum Sativum (Parsley) Leaf Powder, Titanium Dioxide (CI 77891), Ext. Yellow 7 (CI 10316), Iron Oxides (CI 77499), Melaleuca Alternifolia (Tea Tree) Flower/Leaf/Stem Extract,
    Curcuma Longa (Turmeric) Root Extract, Green 3 (CI 42053)

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    UNILEVER, TRUMBULL, CT 06611

  • PRINCIPAL DISPLAY PANEL

    AXE ACNE CONTROL

    2% Salicylic Acid

    Carton

  • INGREDIENTS AND APPEARANCE
    AXE ACNE CONTROL 2% SALICYLIC ACID 
    salicylic acid 2% soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-3785
    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
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TURMERIC (UNII: 856YO1Z64F)  
    EXT. D&C YELLOW NO. 7 (UNII: 08F8S9O3I5)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    PARSLEY (UNII: 58FMD0Q0EV)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    PALM ACID (UNII: B6G0Y5Z616)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    PALM KERNEL ACID (UNII: 79P21R4317)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-3785-8127.5 g in 1 CARTON; Type 0: Not a Combination Product11/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/24/2020
    Labeler - CONOPCO, INC. D/B/A/ UNILEVER (001375088)