Label: SOPURE HAND SANITIZER GEL- isopropyl alcohol 70% gel hand sanitizer gel

  • NDC Code(s): 80773-004-01
  • Packager: EnviroServe Chemicals & Cleaners Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 16, 2024

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  • Active Ingredient

    Isopropyl Alcohol 70% v/v. Purpose : Antiseptic

  • SPL UNCLASSIFIED SECTION

  • Purpose

    Hand Sanitizer-Antiseptic

  • Uses

    Hand sanitizing to reduce bacteria on the skin

  • Warnings

    • Flamable. Keep away from fire or flame 
    • For external use only
    • When using this product avoid contact with eyes. In case of eye contact, flush eyes with water 
    • Stop use and ask a doctor if irritation or rash appears and lasts
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • When using

    When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse, stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

  • Stop use section

    Stop use and ask a doctor if irritation or rash occurs. These may be a sign of a serious condition.

  • Keep out of reach of children

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

  • Directions

    • Dispense enough product in your palm to cover hands and rub hands together briskly until dry
    • Children under 6 years of age should be supervised when using this product
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freesing and excessive heat above 43C (110F)
  • Inactive ingredients

    Glycerin, Polysorbate 20, Amino Methyl Propanol, purified water USP, Vitamin E, Carbomer

  • Package Label- Principal Display Panel

    16.9 FL OZ (500 mL) NDC: 80773-004-01

  • SoPure hand Sanitizer

    Label

  • INGREDIENTS AND APPEARANCE
    SOPURE HAND SANITIZER GEL 
    isopropyl alcohol 70% gel hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80773-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.0133 mL  in 1 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.0045 mL  in 1 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.0035 mL  in 1 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.003 mL  in 1 mL
    WATER (UNII: 059QF0KO0R) 0.2747 mL  in 1 mL
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 0.001 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80773-004-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/16/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)02/16/2024
    Labeler - EnviroServe Chemicals & Cleaners Ltd (243690711)
    Establishment
    NameAddressID/FEIBusiness Operations
    EnviroServe Chemicals & Cleaners Ltd243690711manufacture(80773-004)
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