Label: ACNE SPOT TREATMENT WALGREENS- salicylic acid 2% stick

  • Category: HUMAN OTC DRUG LABEL

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 February 19, 2018

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  • ACTIVE INGREDIENT

    Active ingredients                    Purpose

    Salicylic Acid….2%                    Acne Treatment

  • PURPOSE

  • Uses

    For the treatment of acne

  • WarningsFor external use onlyFlammable. Keep away from fire or flame.

    When using this product skin irritation and dryness is more likely 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

  • DOSAGE & ADMINISTRATION

    Directions
    Cleanse thoroughly before applying treatment
    Cover the entire affected area with a thin layer one to three times daily.
    Because of excessive drying of the skin may occurs, 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 usage to once a day or every other day.

  • Inactive ingredients

    Beeswax
    Eucalyptus Globulus Leaf Oil
    Fragrance
    Myristica Fragrans (Nutmeg) Kernel Oil
    Petrolatum
    Ricinus Communis (Castor) Seed Oil
    Thymol
    Thuja Occidentalis Leaf Oil
    Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ACNE SPOT TREATMENT  WALGREENS
    salicylic acid 2% stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1115
    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
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    Petrolatum (UNII: 4T6H12BN9U)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    Thymol (UNII: 3J50XA376E)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1115-011 in 1 CARTON01/15/2016
    120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/15/2016
    Labeler - Walgreens (008965063)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(0363-1115) , label(0363-1115)
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