Label: STRIDEX SENSITIVE- salicylic acid liquid

  • NDC Code(s): 10157-1007-1, 10157-1007-2, 10157-1007-3, 10157-1007-4
  • Packager: Blistex Inc
  • 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 December 26, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic acid 0.5% (w/w)

  • Purpose

    Acne medication

  • Uses

    • for the treatment and management of acne
    • reduces the number of acne pimples and blackheads and allows the skin to heal
    • helps to 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

    using other topical acne medication at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    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 medication
    • use the pad to wipe the entire affected area
    • repeat with a clean pad as necessary to remove remaining traces of dirt
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily as needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
    • do not leave pad on skin for an extended period of time
    • keep away from eyes, lips and other mucous membranes
  • Inactive ingredients

    aloe barbadensis leaf juice, ammonium lauryl sulfate, ammonium xylenesulfonate, citric acid, DMDM hydantoin, fragrance, hamamelis virginiana (witch hazel) extract, menthol, PPG-5-Ceteth-20, purified water, simethicone, sodium borate, tetrasodium EDTA.

  • PRINCIPAL DISPLAY PANEL - 90 Pad Jar Carton

    NDC 10157-1007-2

    SINGLE-STEP
    ACNE CONTROL™

    ALCOHOL
    FREE

    STRIDEX®
    SALICYLIC ACID 0.5% W/W ACNE MEDICATION

    SENSITIVE WITH ALOE

    90

    SOFT
    TOUCH
    PADS

    Principal Display Panel - 90 Pad Jar Carton
  • INGREDIENTS AND APPEARANCE
    STRIDEX   SENSITIVE
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-1007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    ammonium lauryl sulfate (UNII: Q7AO2R1M0B)  
    ammonium xylenesulfonate (UNII: 4FZY6L6XCM)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    DMDM hydantoin (UNII: BYR0546TOW)  
    hamamelis virginiana top (UNII: UDA30A2JJY)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PPG-5-ceteth-20 (UNII: 4AAN25P8P4)  
    water (UNII: 059QF0KO0R)  
    sodium borate (UNII: 91MBZ8H3QO)  
    edetate sodium (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-1007-11 in 1 CARTON12/01/2012
    155 in 1 JAR
    12 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:10157-1007-21 in 1 CARTON12/01/2012
    270 in 1 JAR
    22 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    3NDC:10157-1007-31 in 1 CARTON12/01/2012
    390 in 1 JAR
    32 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    4NDC:10157-1007-41 in 1 CARTON12/01/2012
    4110 in 1 JAR
    42 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/01/2012
    Labeler - Blistex Inc (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc005126354MANUFACTURE(10157-1007)
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