Label: A.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 April 21, 2010

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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
    • 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, fragrance, purified water, triethanolamine

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

  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – A.B.H.C. INSTANT HAND SANITIZER Citrus Scent

    NDC 61010-2111-9

    SAFETEC A.B.H.C. INSTANT HAND SANITIZER Kills 99.9% of Germs, Enriched with Aloe vera 275 Gallons (1041 L)

    Manufactured by Safetec of America, Inc. Buffalo, NY 14215
    www.safetec.com 800-456-7077

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – A.B.H.C. INSTANT HAND SANITIZER Citrus Scent
  • INGREDIENTS AND APPEARANCE
    A.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-2111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol665 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    Aloe (UNII: V5VD430YW9)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-2111-91041 L in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33305/01/2010
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE
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