Label: STRIDEX CONDITIONING ACNE SCRUB- 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 15, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic acid 2.0% (w/w)

  • Purpose

    Acne treatment

  • 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

    • wet face
    • cover the entire affected area with a thin layer, massaging gently, and rinse thoroughly, use 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

    acrylates copolymer, ammonium lauryl sulfate, citrus aurantium bergamia (bergamot) fruit oil, cocamidopropyl betaine, disodium cocoyl glutamate, disodium EDTA, DMDM hydantoin, fragrance, glycerin, honey, lauryl glucoside, malpighia glaba (acerola) fruit extract, maltodextrin, menthol, mica, polyethylene, purified water, sodium cocoyl glutamate, sodium hydroxide, sodium laureth sulfate, sodium lauroyl sarcosinate, titanium dioxide, tocopheryl acetate.

  • PRINCIPAL DISPLAY PANEL - 177mL Tube Label

    NDC 10157-1042-1

    SINGLE-STEP
    ACNE CONTROL®

    New!

    STRIDEX®
    SALICYLIC ACID 2.0% W/W ACNE MEDICATION

    CONDITIONING
    ACNE SCRUB

    WITH SUPER-FINE
    EXFOLIATING SPHERES

    SCRUBS PORES
    WITHOUT SCRATCHING

    SMOOTHES SKIN

    TREATS & PREVENTS ACNE

    SOOTHES & COOLS

    PLUS

    VITAMINS & BOTANICALS
    Acerola, Bergamot & Honey Extract

    6 fl oz (177ml)

    Principal Display Panel - 177mL Tube Label
  • INGREDIENTS AND APPEARANCE
    STRIDEX CONDITIONING ACNE SCRUB 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-1042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ammonium lauryl sulfate (UNII: Q7AO2R1M0B)  
    bergamot oil (UNII: 39W1PKE3JI)  
    cocamidopropyl betaine (UNII: 5OCF3O11KX)  
    disodium cocoyl glutamate (UNII: MBK0CP8F5A)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    DMDM hydantoin (UNII: BYR0546TOW)  
    glycerin (UNII: PDC6A3C0OX)  
    honey (UNII: Y9H1V576FH)  
    lauryl glucoside (UNII: 76LN7P7UCU)  
    malpighia glabra fruit (UNII: B94O42LA9M)  
    maltodextrin (UNII: 7CVR7L4A2D)  
    menthol (UNII: L7T10EIP3A)  
    mica (UNII: V8A1AW0880)  
    high density polyethylene (UNII: UG00KM4WR7)  
    water (UNII: 059QF0KO0R)  
    sodium cocoyl glutamate (UNII: BMT4RCZ3HG)  
    sodium hydroxide (UNII: 55X04QC32I)  
    sodium laureth-3 sulfate (UNII: BPV390UAP0)  
    sodium lauroyl sarcosinate (UNII: 632GS99618)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-1042-1177 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D12/31/2012
    Labeler - Blistex Inc (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc005126354MANUFACTURE(10157-1042)
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