UNITED LABORATORIES 464 PUMP AND PROTECT ALCOHOL HAND SANITIZER (ALCOHOL) GEL [UNITED LABORATORIES INC.]

UNITED LABORATORIES 464 PUMP AND PROTECT ALCOHOL HAND SANITIZER (ALCOHOL) GEL [UNITED LABORATORIES INC.]
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NDC 63998-515-88
Set ID 3b181944-95c5-4e63-b998-e7b90b7db358
Category HUMAN OTC DRUG LABEL
Packager United Laboratories Inc.
Generic Name
Product Class
Product Number
Application Number PART333
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient:

    Ethanol (60% v/v)

  • Purpose:

    Anti-Microbial Hand Sanitizer

  • Uses

    • Helps reduce bacteria that potentially can cause disease
    • Helps prevent cross contamination by hand contact
    • Recommended for repeated use
  • Warnings

    • For external use only
    • Flammable, keep away from fire, heat, or flame
    • Keep out of reach of children.

    Do not use near eyes • In case of eye contact flush with water for 15 minutes • If irritation persists stop use of product and get medical attention • In case of accidental ingestion seek medical attention or contact a poison control center immediately.

  • Directions

    • Use no water or towels
    • Apply appropriate amount of product to palm of hand
    • Rub until hands are completely covered
    • Agitate lightly until dry
    • Let air dry for 15 seconds
    • Do not rinse or wipe with towel.
  • Other Information

    • Store in a cool dry place below 104° F.
  • Inactive Ingredients

    Water, Carbomer, Triethanolamine, PEG-75 Lanolin, Aloe Vera Gel, Fragrance.

  • Principal Display Panel

    UNITED 464
    LABORATORIES
    PUMP & PROTECT
    Alcohol Hand Sanitizer

    • Enhanced with Moisturizers
    • Kills disease causing germs within seconds
    • Effective against MRSA, VRE, E. coli (0157:H7) Staphylococcus, Streptococcus and other organisms
    • Assists with OSHA Bloodborne Pathogen Standard Compliance

    See Drug Facts panel for additional information.
    For Hospital and Professional Use Only

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    UNITED LABORATORIES 464 PUMP AND PROTECT ALCOHOL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63998-515
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol600 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    carbomer homopolymer type C (UNII: 4Q93RCW27E)  
    aloe (UNII: V5VD430YW9)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63998-515-88237 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33303/21/2010
    Labeler - United Laboratories Inc. (001759737)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canberra Corporation068080621MANUFACTURE

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