Label: STRIDEX ESSENTIAL- salicylic acid liquid

  • 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 8, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic acid 1.0% (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
    • use the pad to 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
    • do not leave pad on skin for an extended period of time
    • keep away from eyes, lips and other mucous membranes
  • Other information

    • DO NOT FLUSH - discard pad in trash and wash hands after use
  • Inactive ingredients

    ammonium lauryl sulfate, ammonium xylenesulfonate, ethylhexylglycerin, fragrance, menthol, phenoxyethanol, purified water, simethicone, sodium ascorbyl phosphate, sodium citrate, sodium hydroxide, tetrasodium EDTA, tocopheryl acetate

  • PRINCIPAL DISPLAY PANEL - 55 Pad Jar Carton

    EASY ON SKIN –
    TOUGH ON ACNE®

    ALCOHOL
    FREE

    STRIDEX®
    SALICYLIC ACID 1% W/W ACNE MEDICATION

    ESSENTIAL WITH VITAMINS

    55
    SOFT
    TOUCH
    PADS

    Cleans • Treats • Prevents

    PRINCIPAL DISPLAY PANEL - 55 Pad Jar Carton
  • INGREDIENTS AND APPEARANCE
    STRIDEX ESSENTIAL 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-2119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Ammonium Xylenesulfonate (UNII: 4FZY6L6XCM)  
    Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-2119-11 in 1 CARTON12/06/2022
    155 in 1 JAR
    12 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/06/2022
    Labeler - Blistex Inc (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc005126354MANUFACTURE(10157-2119)
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