Label: INSTA-CLEAN HAND SANITIZER GEL- ethyl alcohol gel

  • Contains inactivated NDC Code(s)
    NDC Code(s):     79386-337-01, 79386-337-02, 79386-337-03, 79386-337-04, view more
    79386-337-05, 79386-337-06, 79386-337-07, 79386-337-08, 79386-337-09, 79386-337-13, 79386-337-14, 79386-337-15
  • Packager: Tr International Trading Company
  • 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 7, 2020

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  • Drug Facts

  • Active ingredient 

    Ethyl Alcohol 70% v/v 

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin
    • recommended for repeated use
    • for use when soap and water are not available

  • Warnings

    Flammable, keep away from fire/flame
    For external use only

    Do not use
    • on children less than 2 months of age
    • on open skin wounds

    When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if
    • irritation and redness develop
    • 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

    • wet hands thoroughly with product and allow to dry without wiping
    • supervise children under 6 years of age when using this product to avoid swallowing
    • not recommended for infants

  • Other information

    • store between 15-30°C (59-86°F)
    • avoid freezing and excessive heat above 40°C (104°F).

  • Inactive ingredients

    acrylates/vinyl isodecanoate cross-polymer, aminomethylpropanol, glycerin, PEG-6, water

  • Questions? +1-206-505-3500

    You may also report serious side effects to this phone number.
    Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    Ethyl Alcohol 70% - Topical Gel

    UNSCENTED

    MADE IN THE USA

    WARNING

    Extremely Flammable.
    Keep away from flame.

    Distributed by:

    TRINTERNATIONAL, INC.

    600 Stewart Street, Suite 301, Seattle, WA 98101

    WWW.TRICHEMICALS.COM

    Infotrac 24-Hour Ph

    +1-800-535-5053 Acct #79932

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    INSTA-CLEAN HAND SANITIZER GEL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79386-337
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79386-337-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    2NDC:79386-337-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    3NDC:79386-337-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    4NDC:79386-337-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    5NDC:79386-337-05237 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    6NDC:79386-337-06296 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    7NDC:79386-337-07355 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    8NDC:79386-337-08473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    9NDC:79386-337-09500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    10NDC:79386-337-131000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    11NDC:79386-337-143785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    12NDC:79386-337-1518927.1 mL in 1 CONTAINER; Type 0: Not a Combination Product07/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/20/2020
    Labeler - Tr International Trading Company (868851247)
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