Label: WALGREENS ACNE CONTROL GEL- salicylic acid gel

  • 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 July 5, 2023

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

  • Active ingredient

    Salicylic acid 2.0%

  • Purpose

    Acne Treatment

  • Uses

    • For the treatment of acne
    • clears acne blemishes and allows skin to heal
    • helps prevent new acne blemishes from forming
  • 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.
    • avoid contact with eyes. If contact occurs, flush thoroughly with water.
  • Keep out of reach of children.

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

  • Directions

    • cleanse 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.
  • Other information

    • may stain some fabrics
  • Inactive ingredients

    behentrimonium methosulfate, carbomer, ceramide AP, ceramide EOP, ceramide NP, cetearyl alcohol, cetyl alcohol, chlorphenesin, cholesterol, disodium EDTA, glycerin, glycolic acid, guar hydroxypropyltrimonium chloride, lactic acid, niacinamide, phytosphingosine, sodium hyaluronate, sodium hydroxide, sodium lauroyl lactylate, water, xanthan gum

  • Label

    W08749A

    W08749K

  • INGREDIENTS AND APPEARANCE
    WALGREENS ACNE CONTROL GEL 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0269
    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
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    CERAMIDE NP (UNII: 4370DF050B)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0269-831 in 1 CARTON05/02/2023
    140 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00605/02/2023
    Labeler - WALGREEN COMPANY (008965063)