Label: DIFFERIN ACNE CLEARING BODY- salicylic acid aerosol, spray

  • NDC Code(s): 0299-4132-00
  • Packager: Galderma Laboratories, L.P.
  • 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 May 6, 2022

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

  • SPL UNCLASSIFIED SECTION

  • Active Ingredient

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Use

    For the management 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.

  • Stop use and ask a doctor if

    • irritation becomes severe.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    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 below. • 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.

  • Inactive Ingredients

    Water, Alcohol Denat., Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Water, Polysorbate 20, Ammonium Hydroxide, Disodium EDTA

  • Questions or comments? 1-866-735-4137

    Distributed by: Galderma Laboratories, L.P.,
    Fort Worth, TX 76177 USA
    All trademarks are the property of their respective owners.
    www.differin.com
    P56873-0

  • PRINCIPAL DISPLAY PANEL - 6 OZ bottle


    NEW

    DIFFERIN®

    ACNE
    TREATMENT
         

    ACNE - CLEARING
    BODY SPRAY

    2% Salicylic Acid

    Maximum strength OTC ingredient
    helps eliminate acne bumps, pimples,
    and blackheads

    Contains Witch Hazel to soothe the skin

    360° Continuous Non-Aerosol Spray


    NET WT 6 OZ (170 g)

    084181-P56873-0-Differn-Body-Spray-6oz-Bottle
  • INGREDIENTS AND APPEARANCE
    DIFFERIN ACNE CLEARING BODY 
    salicylic acid aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4132
    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
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Glycolic Acid (UNII: 0WT12SX38S)  
    Hamamelis Virginiana Top Water (UNII: NT00Y05A2V)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Ammonia (UNII: 5138Q19F1X)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4132-00170 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/01/2022
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit of The Earth, Inc080086802manufacture(0299-4132)