Label: GELPHRESH- 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 10, 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, cocamidopropyl betaine, hydroxypropyl methylcellulose

  • PRINCIPAL DISPLAY PANEL - 18.9 L Jug Label

    Prevenio

    Gelphresh

    Isopropyl Alcohol Antiseptic 75% (Gel)
    Topical Solution
    Hand Sanitizer
    Non-sterile Solution

    DANGER

    Hazard Statements: Highly flammable liquid and vapor. Causes serious eye
    irritation. May cause drowsiness or dizziness.

    Precautionary Statements: Keep away from heat, open flames, sparks -- No
    smoking. Keep container tightly closed. Ground/bond container and receiving
    equipment. Use explosion-proof electrical, ventilating
    away from clothing. Use only non-sparking tools. Take precautionary measures
    against static discharge. Avoid breathing dust, fume, gas, mist, vapors and spray.
    Wear protective gloves, clothing, eye and 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, seek medical advice/attention.
    SPECIFIC TREATMENT: (See First Aid section on the SDS.) Rinse mouth.
    Wash contaminated clothing before reuse.
    IN CASE OF FIRE: Use dry san, dry chemical or alcohol-resistant foam to extinguish.
    Store in a well-ventilated place. Keep container tightly closed. Store in well-
    ventilated place. Keep cool. Store locked up.
    Dispose of contents/container to licensed waste handling facility.

    UPC
    CODE
    PLACEHOLDER

    MADE
    IN THE
    USA

    NET CONTENTS: 5 GAL / 18.9 L

    LOT #: _____________________

    CMS PRODUCT # 8005

    UN 1987

    UN 1987, ALCOHOLS, N.O.S.,
    (ISOPROPYL ALCOHOL), 3, PG III

    FOR SPILL EMERGENCIES 24-HOUR

    CALL INFOTRAC @ 800.535.5053 (US & Canada) | 352.323.3500 (Outside US & Canada)
    PLEASE REFERENCE SDS FOR ADDITIONAL INFORMATION

    KEEP OUT OF THE REACH OF CHILDREN.
    FOR INDUSTRIAL OR FOOD PLANT USE ONLY

    PROTECTING
    BRANDS by
    PROTECTING
    LIVES

    Prevenio | 10 Finderne Avenue | Bridgewater, NJ 08807 | 908.707.1092 | www.prevenio.com

    PRINCIPAL DISPLAY PANEL - 18.9 L Jug Label
  • INGREDIENTS AND APPEARANCE
    GELPHRESH 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54555-130
    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:54555-130-041040.9 L in 1 TANK; Type 0: Not a Combination Product06/03/2020
    2NDC:54555-130-03208.1 L in 1 DRUM; Type 0: Not a Combination Product06/03/2020
    3NDC:54555-130-0218.9 L in 1 JUG; Type 0: Not a Combination Product06/03/2020
    4NDC:54555-130-013.785 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(54555-130) , LABEL(54555-130) , PACK(54555-130) , REPACK(54555-130)
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