Label: ANTIMICROBIAL- alcohol liquid

  • 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 7, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Ethyl Alcohol 66.5%

  • Purpose

    Antiseptic

  • Uses

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

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

    Do not use in the eyes. If this happens, rinse thoroughly with water.

    Stop use and ask doctor if

    • irritation or 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

    • wet hands and wrists thoroughly for 15 seconds and allow to air dry
    • always reseal after use
    • children under 6 years of age should be supervised when using this product
  • Inactive ingredients

    Aloe vera, fragrance, purified water, triethanolamine

    SAFETEC OF AMERICA, Inc.
    887 Kensington Ave. Buffalo, NY 14215
    800-456-7077 www.safetec.com

    Reorder no. 34421
    275 Gal. (1,041 L)

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL – 275 Gallon Container Label

    NDC 61010-3200-0

    Safetec

    p.a.w.s.

    Antimicrobial Liquid

    • Kills 99.9% of Germs!
    • Contains 66.5% Ethyl Alcohol
    • Enriched with Aloe Vera

    Citrus Scent

    SAFETEC OF AMERICA, Inc.

    887 Kensington Ave. Buffalo, NY 14215

    800-456-7077 www.safetec.com

    Reorder no. 34421

    275 Gal. (1,041 L)

    PRINCIPAL DISPLAY PANEL – 275 Gallon Container Label
  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-3200
    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)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-3200-01041 L in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/07/2011
    Labeler - Safetec of America (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE
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