FDA.reportPublic FDA data

NewTralize Gel

Manufacturer
Newpark Industrial Blending Solutions LLC | Custom Chemical Services, LLC
Effective date
2021-11-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:44:59

Label at a glance#

ProductNewTralize Gel
Active ingredientALCOHOL
Label structure13 sections

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

OTC - PURPOSE SECTION

Purpose
Antiseptic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

Do not use

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, purified
water, polyethylene glycol and carbomer copolymer

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEWPARK

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

NewTralize™ Gel
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

002-01 320GAL002-01 320GAL

002-02 265GAL002-02 265GAL

002-03 1GAL002-03 1GAL

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75519-002-012023-01-30C16284748780-1f386c649-c321-0266-e053-dadaa90a7c1aNewTralize ​™ Gel Instant Hand Sanitizer
75519-002-022023-01-30C16284748780-1f386c649-c321-0266-e053-dadaa90a7c1aNewTralize ​™ Gel Instant Hand Sanitizer
75519-002-032023-01-30C16284748780-1f386c649-c321-0266-e053-dadaa90a7c1aNewTralize ​™ Gel Instant Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75519-002-01NewTralize Gel1211 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL12113
75519-002-02NewTralize Gel1003 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL10033
75519-002-03NewTralize Gel3.79 L in 1 BOTTLE, PLASTICGEL3.793

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75519-002NEWTRALIZE GEL (ALCOHOL) GEL [NEWPARK INDUSTRIAL BLENDING SOLUTIONS LLC]3Legacy NDC, 3 package rows20211120_60f14dc2-3f4c-4d9f-a0e0-46c644064a4b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75519-00275519-002-01, 75519-002-02, 75519-002-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4aba66f2-b4d9-4aba-8d61-e38c995d255760f14dc2-3f4c-4d9f-a0e0-46c644064a4b2021-11-18WarningsExact identifier
spl id: 4aba66f2-b4d9-4aba-8d61-e38c995d2557
spl set id: 60f14dc2-3f4c-4d9f-a0e0-46c644064a4b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.