Label: TERRAGEL- alcohol liquid

  • 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 June 5, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient[s]

    Isopropyl alcohol 75% v/v

  • Purpose

    Antiseptic

  • Use[s]

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

    Do not use

    • in children less than 2 months of age
    • on open skin wounds

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    hydrogen peroxide, purified water USP, d'limonene, cocoamidopropyl betaine, hydroxypropyl methylcellulose

  • PRINCIPAL DISPLAY PANEL - 1320 Liter Tank Label

    brainerd

    TERRAGEL

    Chemical Distribution Network

    RESPONSIBLE
    nacd
    VERIFIED
    DISTRIBUTION™

    !
    UN1987

    FLAMMABLE LIQUID
    3

    MADE IN U.S.A.

    DANGER

    HAZARD STATEMENTS
    Highly flammable liquid and vapor.
    Causes serious eye irritation.
    May cause drowsiness or dizziness.
    PRECAUTIONARY STATEMENTS
    Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
    Keep container tightly closed.
    Ground/bond container and receiving equipment.
    Use explosion-proof electrical/ventilating/lighting equipment.
    Use only non-sparking tools.
    Take precautionary measures against static discharge.
    Avoid breathing dust/fume/gas/mist/vapors/spray.
    Wear protective gloves/protective clothing/eye protection/face protection.
    IF IN EYES: Rinse cautiously with water for several minutes. Remove contact
    lenses, if present and easy to do. Continue rinsing.
    If eye irritation persists: Get medical advice/attention.
    In case of fire: Use dry sand/dry chemical/alcohol-resistant foam for
    extinction.
    Store in a well-ventilated place. Keep cool.
    Store locked up.
    Dispose of contents/container to an approved waste disposal facility.

    EMPTY CONTAINERS: Do not use container for any other purpose. Container
    may contain hazardous residue. Follow all safety requirements as if full. Do
    not cut, braze, or weld on or near this container.

    World Health Organization Blend Formulation #2

    UN1987, ALCOHOLS, N.O.S. (Isopropyl Alcohol), 3, PG III

    PRODUCT CODE

    NET CONTENTS

    PACK INFO

    LOT NUMBER

    For Spill Emergencies 24 hour
    Call Chemtrec 1-800-424-9300

    FOR ADDITIONAL
    INFORMATION SEE SDS

    NATIONAL POISON CONTROL CENTER
    1-800-222-1222

    PRINCIPAL DISPLAY PANEL - 1320 Liter Tank Label
  • INGREDIENTS AND APPEARANCE
    TERRAGEL 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54555-129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) alcohol750 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    hydrogen peroxide (UNII: BBX060AN9V)  
    water (UNII: 059QF0KO0R)  
    LIMONENE OXIDE, TRANS-(+)- (UNII: 8VUQ1B30IK)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54555-129-041320 L in 1 TANK; Type 0: Not a Combination Product06/03/2020
    2NDC:54555-129-03220 L in 1 DRUM; Type 0: Not a Combination Product06/03/2020
    3NDC:54555-129-0220 L in 1 JUG; Type 0: Not a Combination Product06/03/2020
    4NDC:54555-129-014 L in 1 JUG; Type 0: Not a Combination Product06/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A06/03/2020
    Labeler - Brainerd Chemical Company Inc., (787442417)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brainerd Chemical Company Inc.,787442417MANUFACTURE(54555-129) , LABEL(54555-129) , PACK(54555-129) , REPACK(54555-129)
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