Label: INSTANT HAND SANITIZER- alcohol gel 

  • Label RSS
  • NDC Code(s): 61010-7111-0
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Ethyl Alcohol 70%

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  • Purpose

    Antiseptic

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  • 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
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  • 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

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  • 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
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  • Inactive ingredients

    Aloe vera, carbomer, purified water, triethanolamine

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

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  • 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
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  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61010-7111
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    alcohol (alcohol) alcohol 700 mg  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    aloe vera leaf  
    carbomer interpolymer type a (55000 mpa.s)  
    water  
    trolamine  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61010-7111-0 1026 L in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 11/06/2013
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec of America, Inc. 874965262 MANUFACTURE(61010-7111)
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