Label: ENVIROKLEEN INSTANT HAND SANITIZER- alcohol gel

  • 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 9, 2011

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  • 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
  • Warning

    • 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

    ECS Envirokleen Instant Hand Sanitizer

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

    See Drug Facts panel for additional information.
    For Hospital And Professional Use Only
    Envirokleen, LLC
    3313 South Arlington Avenue
    Indianapolis, Indiana 46203
    Phone 317-352-1941 Fax 317-352-1946
    Website: www.ecsenvirokleen.com

    “Environmental Cleaning Solutions”

    Align the half moon ears (round side out) with
    the slots of the dispenser's lower docking area.
    Press top and bottom of tube firmly into place.

    KEEP OUT OF REACH OF CHILDREN.Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    ENVIROKLEEN INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50112-515
    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:50112-515-80800 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/09/2011
    Labeler - EnviroKleen LLC (791610038)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canberra Corporation068080621MANUFACTURE
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