Label: ETHYL 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 November 20, 2009

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  • ACTIVE INGREDIENT

    Ethyl Alcohol, 70% v/v

  • PURPOSE

    Antiseptic

  • USES

    For handwashing when water is not available to decrease bacteria on the skin

    • after changing diapers.
    • after assisting ill persons.
    • before contact with a person under medical care or treatment.
    • recommended for repeated use.
  • WARNINGS

    For external use only.
    Flammable, keep away from fire or flame.

    Do not use

    in the eyes




    Stop use and ask a doctor

    • if irritation and redness develop.
    • if condition persists for more than 72 hours



    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • Place a palmful of product in one hand.
    • Spread on both hands and rub into skin until dry (approx. 1-2 min.).
    • Place a smaller amount into one hand.
    • Spread over hands to wrist and rub into skin until dry
  • SPL UNCLASSIFIED SECTION


  • OTHER INFORMATION

    Store at room temperature: 15° - 30° C (59° - 86° F).
  • Inactive ingredients

    aloe vera gel, Bitrex, carbomer 940, fragrance, PEG-1450, t-butyl alcohol, triethanolamine, water
  • QUESTIONS


  • PACKET INFORMATION

    TRIAD®

    Cat. No. 10-8672

    Ethyl Alcohol, 70% v/v
    ANTISEPTIC
    HAND GEL

    Helps meet CDC, OSHA and APIC
    Guidelines for Hand Hygiene
    Triad Group, Inc.
    700 West North Shore Drive
    Hartland, WI 53029 USA

    Contents:
    Net Wt. 5 grams

    foil

  • CARTON INFORMATION

    TRIAD®

    Cat. No. 10-8672         NDC 50730-8672-0

    Antiseptic
    Hand Gel

    • 70% Ethyl Alcohol, v/v
    • Helps meet CDC, OSHA and APIC Guidelines for Hand Hygiene
    • Contains Aloe Vera Gel

    72 Packets
    Net. Wt. 5 grams each

    Triad Group, Inc.
    700 West North Shore Drive
    Hartland, WI 53029

    MADE IN USA
    www.triad-group.net
    1-800-288-1288



    carton

  • INGREDIENTS AND APPEARANCE
    ETHYL ALCOHOL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-8672
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol.70 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    carbomer homopolymer type c (UNII: 4Q93RCW27E)  
    denatonium benzoate (UNII: 4YK5Z54AT2)  
    polyethylene glycol 1450 (UNII: OJ4Z5Z32L4)  
    tert-butyl alcohol (UNII: MD83SFE959)  
    trolamine (UNII: 9O3K93S3TK)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-8672-072 in 1 BOX
    15 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33311/17/1997
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
    Registrant - H and P Industries, Inc. dba Triad Group (050259597)
    Establishment
    NameAddressID/FEIBusiness Operations
    H and P Industries, Inc. dba Triad Group050259597manufacture
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