Label: BLISTEX STRIDEX SPOT AND T-ZONE ACNE CLEARGEL- 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 November 24, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic acid 2.0% (w/w)

  • Purpose

    Acne medication

  • Uses

    • for the treatment of acne
    • reduces the number of acne pimples and blackheads and allows skin to heal
    • helps prevent new acne pimples from forming
  • Warnings

    For external use only

    Allergy alert:

    do not use this product if you have a known allergy to salicylic acid

    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.

    Keep out of reach of children.

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

  • Directions

    • 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
    • keep away from eyes, lips and other mucous membranes
  • Inactive ingredients

    aloe barbadensis leaf juice (decolorized), citric acid, ethylhexylglycerine, hamamelis virginiana (witch hazel) water, phenoxyethanol, purified water, PVM/MA decadiene crosspolymer, sodium borate, sodium hydroxide, tetrasodium EDTA

  • PRINCIPAL DISPLAY PANEL - 28.35 g Jar Carton

    STRIDEX®
    SALICYLIC ACID 2% W/W ACNE MEDICATION

    SPOT & T-ZONE
    ACNE CLEARGEL

    new!

    Focused Treatment For Problem Areas

    Net Wt. 1 oz. (28.35 g)

    Principal Display Panel - 28.35 g Jar Carton
  • INGREDIENTS AND APPEARANCE
    BLISTEX STRIDEX SPOT AND T-ZONE ACNE CLEARGEL 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-2101
    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)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MALEIC ANHYDRIDE (UNII: V5877ZJZ25)  
    1,9-DECADIENE (UNII: 2KWZ01G244)  
    METHYL VINYL ETHER (UNII: G2OHX46576)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-2101-11 in 1 CARTON
    128.35 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D01/04/2016
    Labeler - Blistex Inc (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc005126354MANUFACTURE(10157-2101)
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