Label: INSTANT HAND SANITIZER- alcohol gel

  • NDC Code(s): 61010-7111-0
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    • for handwashing to decrease bacteria on skin whenever soap and water handwashing is not readily available
    • helps prevent the risk of cross-contamination of bacteria that potentially can cause disease or infection
    • recommended for repeated use
  • Warnings

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

    When using this product

    • do 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 into one hand
    • spread over both hands and wrist
    • rub into the skin until dry
    • do not wipe off; no rinsing required
  • Inactive ingredients

    Aloe vera, carbomer, purified water, triethanolamine

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

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL – 34,688 fl. oz. Container Label

    NDC 61010-7111-0

    Safetec

    instant

    Hand

    Sanitizer

    Kills 99.9% of Germs

    Enriched with

    Aloe Vera

    Unscented

    34,688 fl.oz. (1,026 L) Reorder No. 17393

    PRINCIPAL DISPLAY PANEL – 34,688 fl. oz. Container Label
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-7111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 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:61010-7111-01026 L in 1 CONTAINER; Type 0: Not a Combination Product11/06/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)11/06/2013
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(61010-7111)
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