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KE-53PS Hand Sanitizer (Kinzua Environmental Inc.)

Available Formats

Dosage Form Package Information Links
GEL 118 mL in 1 BOTTLE (64121-515-27) Label Information

Complete KE-53PS Hand Sanitizer Information

  • 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


  • Principal Display Panel – Bottle Label

    KE-53PS
    Gel 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

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

    12-266-1362
    Manufactured for:
    KINZUA ENVIRONMENTAL, Inc.
    1176 E. 38th. CLEVELAND, OH 44114
    1-800-233-5079

    Principal Display Panel – Bottle Label

  • INGREDIENTS AND APPEARANCE
    KE-53PS HAND SANITIZER 
    ethanol gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:64121-515
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ethanol (UNII: 3K9958V90M) (ethanol - UNII:3K9958V90M) ethanol 600 mL  in 1000 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    carbomer homopolymer type C (UNII: 4Q93RCW27E)  
    aloe (UNII: V5VD430YW9)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64121-515-27 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333 05/21/2010
    Labeler - Kinzua Environmental Inc. (612966374)
    Establishment
    Name Address ID/FEI Business Operations
    Canberra Corporation 068080621 MANUFACTURE