Label: ANTIMICROBIAL- alcohol liquid

  • NDC Code(s): 61010-3111-1, 61010-3111-2, 61010-3111-3, 61010-3111-4
  • Packager: Safetec of America, Inc.
  • 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 May 21, 2012

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

  • 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 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. 34409

    275 Gal. (1,041 L)

  • PRINCIPAL DISPLAY PANEL – 275 Gallon Container Label

    NDC 61010-3111-4

    Safetec

    p.a.w.s.

    Antimicrobial

    Liquid

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

    Fresh Scent

    Drug Facts

    Active Ingredient Purpose

    Ethyl Alcohol 66.5% 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. 34409

    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:61010-3111
    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:61010-3111-41041 L in 1 CONTAINER; Type 0: Not a Combination Product05/21/2012
    2NDC:61010-3111-1100 in 1 BOX05/21/2012
    20.0019 L in 1 PACKET; Type 0: Not a Combination Product
    3NDC:61010-3111-20.224 L in 1 CANISTER; Type 0: Not a Combination Product05/21/2012
    4NDC:61010-3111-30.58 L in 1 CANISTER; Type 0: Not a Combination Product05/21/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/21/2012
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(61010-3111)