Label: ALCO-SAN INSTANT SKIN 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 May 21, 2010

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  • 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

    MARC

    ALCO-SAN

    INSTANT SKIN 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

    Manufactured for:

    MID-AMERICAN RESEARCH CHEMICAL CORP.

    COLUMBUS, NE 68601

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    ALCO-SAN INSTANT SKIN SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64233-515
    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:64233-515-27118 mL in 1 BOTTLE
    2NDC:64233-515-80800 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33305/21/2010
    Labeler - Mid-American Chemical Research Corporation (051254092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canberra Corporation068080621MANUFACTURE
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