Label: INSTANT HAND SANITIZER- alcohol gel

  • NDC Code(s): 61010-8700-1
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 4, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 66.5%

  • Purpose

    Antiseptic

  • Uses

    • for handwashing to decrease bacteria on skin whenever soap and water handwashing is not readily available
  • Warnings

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

    When using this productdo not get into eyes. If contact occurs, rinse eyes thoroughly with water

    Stop use and ask doctor if

    • irritation and redness develop and persists for more than 72 hours

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

  • Directions

    • place a small amount and rub over both hands and wrists until dry
    • allow to dry without wiping
    • children under 6 should be supervised while using this product
  • Inactive ingredients

    aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine

    Manufactured by SAFETEC OF AMERICA, Inc.
    Buffalo, NY 14215 800-456-7077 www.safetec.com

  • PRINCIPAL DISPLAY PANEL – 27.05 fl. oz. Container Label

    NDC 61010-8700-1

    Safetec

    instant

    Hand

    Sanitizer Fresh Scent

    Kills 99.9% of Germs

    Enriched with

    Aloe Vera

    27.05 fl.oz. (800 ML) Reorder No. 17369

    PRINCIPAL DISPLAY PANEL – 27.05 fl. oz. Container Label
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-8700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL665 mg  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-8700-11 in 1 CONTAINER10/15/2013
    10.8 L in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)10/15/2013
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc874965262manufacture(61010-8700)
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