Label: LINSTOL REFRESHING AND CLEANSING HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 21, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 75%

  • Purpose

    Antiseptic

  • Uses

    Hand sanitizer to help reduce bacteria on the skin

  • Warnings

    For external use only

    Flammable. Keep away from fire or flame.

    When using this product do not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use or ask a doctor if irritation or rash appears and lasts.

    • You may report side effects to FDA at 1-800-FDA-1088.

    Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet hands thoroughly with product and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Inactive ingredients

    Water (Aqua), Carbomer, Fragrance, Glycerin, Racementhol, Trolamine.

  • SPL UNCLASSIFIED SECTION

    Distributed by: Linstol USA, LLC
    Naples, FL 34114

  • PRINCIPAL DISPLAY PANEL - 2 ml Packet

    REFRESHING & CLEANSING

    HAND
    SANITISER

    Contains 75% Alcohol

    2ml / 0.07 fl. oz.
    PARABEN & TRICLOSAN FREE

    PRINCIPAL DISPLAY PANEL - 2 ml Packet
  • INGREDIENTS AND APPEARANCE
    LINSTOL REFRESHING AND CLEANSING HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76982-3864
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    RACEMENTHOL (UNII: YS08XHA860)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76982-3864-02 mL in 1 PACKET; Type 0: Not a Combination Product05/20/2020
    2NDC:76982-3864-115 mL in 1 TUBE; Type 0: Not a Combination Product05/20/2020
    3NDC:76982-3864-230 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2020
    4NDC:76982-3864-359 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2020
    5NDC:76982-3864-4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2020
    6NDC:76982-3864-5236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/20/2020
    7NDC:76982-3864-6500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/20/2020
    8NDC:76982-3864-7532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/20/2020
    Labeler - Linstol USA, LLC (828039995)
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