NEWTRALIZE GEL- alcohol gel

NewTralize Gel by

Drug Labeling and Warnings

NewTralize Gel by is a Otc medication manufactured, distributed, or labeled by Newpark Industrial Blending Solutions LLC, Custom Chemical Services, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, purified
water, polyethylene glycol and carbomer copolymer

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

res

INGREDIENTS AND APPEARANCE

NEWTRALIZE GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75519-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75519-002-01	1211 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	07/01/2020
2	NDC: 75519-002-02	1003 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	07/01/2020
3	NDC: 75519-002-03	3.79 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020

Labeler - Newpark Industrial Blending Solutions LLC (117789239)

Registrant - Newpark Industrial Blending Solutions LLC (117789239)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Chemical Services, LLC		078305908	manufacture(75519-002)