Label: EVERWIPE HAND SANITIZER- alcohol gel

  • NDC Code(s): 50157-518-37, 50157-518-44
  • Packager: Brands International
  • 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 March 11, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol, 70% v/v

  • INDICATIONS & USAGE

    Antiseptic skin cleanser

  • Purpose

    Antiseptic (skin) cleanser

  • Warnings

    For external use only. Flammable, keep away from fire or flame.

    When using this product.

    • If contact occurs, rinse thoroughly with water.
    • avoid contact with eyes.

    Stop use and ask a doctor if irritation  develops.

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

  • Directions

    • place enough product on your plam to thoroughly cover your hands
    • rub thoroughly into hands for at least 30 seconds
    • Allow to dry
  • Other Information

    • Store below 43°C (110°F)
    • may discolor certain fabrics or surfaces.

  • Inactive Ingredients

    Carbomer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Glycerin, Propylene glycol, Water, Tocopheryl Acetate (Vit E).

    Isopropyl Alcohol

  • PRINCIPAL DISPLAY PANEL

    12

  • INGREDIENTS AND APPEARANCE
    EVERWIPE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-518
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-518-44443 mL in 1 BOTTLE; Type 0: Not a Combination Product03/11/2021
    2NDC:50157-518-373780 mL in 1 BOTTLE; Type 0: Not a Combination Product03/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/11/2021
    Labeler - Brands International (243748238)
    Registrant - Brands International (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International243748238manufacture(50157-518)
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