Label: 3P INSTANT HAND SANITIZER- ethanol 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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  • 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

    3-P
    INSTANT HAND SANITIZER (GEL-TYPE)

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

    12-266-1362
    Manufactured for:
    3-P SPECIALTY INC. • P.O. BOX 671183
    MARIETTA, GEORGIA • (770) 971-4603

    Principal Display Panel – Bottle Label
  • INGREDIENTS AND APPEARANCE
    3P INSTANT HAND SANITIZER 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64238-515
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ethanol (UNII: 3K9958V90M) (ethanol - UNII:3K9958V90M) ethanol600 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:64238-515-27237 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33303/21/2010
    Labeler - 3-P Specialty Inc. (193951910)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canberra Corporation068080621MANUFACTURE
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