Newtralize​™

Newtralize​™
SPL v3
SPL
SPL Set ID 60f14dc2-3f4c-4d9f-a0e0-46c644064a4b
Route
TOPICAL
Published
Effective Date 2021-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 L)
Inactive Ingredients
Glycerin Hydrogen Peroxide Water Polyethylene Glycol, Unspecified Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only. Flammable. Keep away from heat

or flame.  Keep out of reach of children.

Indications and Usage

Use

Hand Santtizer helps reduce bacteria that potentially

causes disease. Use when soap and water are not

available.

Dosage and 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.
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)
Section 50565-1

Keep out of reach of children. If swallowed, immediately

seek medical attention or contact a Poison Control

Center.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs.

These may be signs of a serious condi􀆟on.

Section 50567-7

When using this product keep out of eyes, ears, and

mouth. In case of contact with eyes, rinse eyes

thoroughly with water.

Section 50570-1

Do not use

  • On children less than 2 months of age, or
  • On open skin wounds
Section 51727-6

Inactive ingredients glycerin, hydrogen peroxide, purified

water, polyethylene glycol and carbomer copolymer

Section 55105-1

Purpose

Antiseptic

Active Ingredient(s)

Alcohol 70% v/v

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


Structured Label Content

Indications and Usage (34067-9)

Use

Hand Santtizer helps reduce bacteria that potentially

causes disease. Use when soap and water are not

available.

Dosage and Administration (34068-7)

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.
Warnings and Precautions (34071-1)

Warnings

For external use only. Flammable. Keep away from heat

or flame.  Keep out of reach of children.

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, immediately

seek medical attention or contact a Poison Control

Center.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs.

These may be signs of a serious condi􀆟on.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and

mouth. In case of contact with eyes, rinse eyes

thoroughly with water.

Section 50570-1 (50570-1)

Do not use

  • On children less than 2 months of age, or
  • On open skin wounds
Section 51727-6 (51727-6)

Inactive ingredients glycerin, hydrogen peroxide, purified

water, polyethylene glycol and carbomer copolymer

Section 55105-1 (55105-1)

Purpose

Antiseptic

Active Ingredient(s)

Alcohol 70% v/v

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

res


Advanced Ingredient Data


Raw Label Data

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