Label: NEWTRALIZE- 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 November 18, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient(s)

    Alcohol 70% v/v

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Use
    Hand Santtizer helps reduce bacteria that potentially
    causes disease. Use when soap and water are not
    available.

  • WARNINGS

    Warnings
    For external use only. Flammable. Keep away from heat
    or flame.  Keep out of reach of children.

  • DO NOT USE

    Do not use

    • On children less than 2 months of age, or
    • On open skin wounds
  • WHEN USING

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

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, immediately
    seek medical attention or contact a Poison Control
    Center.

  • DOSAGE & ADMINISTRATION

    Directions

    • Place enough product on hands to cover all surfaces.
    • Rub hands together until dry.
    • Supervise children under 6 years of age when usingthis product to avoid swallowing.
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients glycerin, hydrogen peroxide and
    purified water

  • Package Label - Principal Display Panel

    NEWPARK

    Newpark Manufacturing
    701 Conroe Park W Dr.
    Conroe, TX 77303
    Telephone: +1(800) 444-0682

    NewTralize™
    INSTANT HAND SANITIZER

    Warning

    Hazard Statements:

    Causes serious eye irritation
    Flammable liquid and vapors

    Precautionary Statements: Wear eye protection if
    splash hazard exists. Keep away from heat, sparks,
    or open flames - No smoking. Keep container tightly
    closed. Use explosion-proof equipment. Use only
    non-sparking tools. Ground or bond container and
    receiving equipment. Take precautionary measures
    against static discharge.

    In case of fire: Use water to extinguish.

    IF IN EYES: Rinse cautiously with water for
    several minutes. Remove contact lenses if
    present an easy to do. Continue rinsing.

    IF EYE IRRITATION PERSISTS: Get medical
    advice or attention.


    D.O.T and Hazard information:

    UN1993

    Flammable Liquid, n.o.s. (Ethanol), 3, PG III
    Prior to use, consult Safety Data Sheet for complete product information.

    Net Content: 320 U.S. Gallons

    001-01 320GAL

    001-02 265GAL

    001-03 1GAL

    res

  • INGREDIENTS AND APPEARANCE
    NEWTRALIZE 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75519-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75519-001-011211 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product07/01/2020
    2NDC:75519-001-021003 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product07/01/2020
    3NDC:75519-001-033.79 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2020
    Labeler - Newpark Industrial Blending Solutions LLC (117789239)
    Registrant - Newpark Industrial Blending Solutions LLC (117789239)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Chemical Services, LLC078305908manufacture(75519-001)