NEW LIFE 3% HYDROGEN PEROXIDE FIRST AID ANTISEPTIC- hydrogen peroxide solution

New Life 3% Hydrogen Peroxide FIRST AID ANTISEPTIC by

Drug Labeling and Warnings

New Life 3% Hydrogen Peroxide FIRST AID ANTISEPTIC by is a Otc medication manufactured, distributed, or labeled by New Life Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Hydrogen Peroxide(stabilized) 3%

Purpose

First aid antiseptic/oral debriding agent

Uses

 First aid to help prevent the risk of infection in minor cuts, scrapes and burns  aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth.

Warnings

For external use only. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Do not use: In the eyes or apply over large areas of the body  Longer than one week

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

Stop use and ask a doctor if swelling, rash, or fever develops  the condition persists or gets worse  sore mouth symptoms do not improve in 7 days  irritation, pain, redness persists or worsens

KEEP OUT OF REACH OF CHILDREN.

Directions

For use as a first aid antiseptic:

clean affected area  apply small amount of product on affected area 1 to 3 times a day if bandaged, let dry first  may be covered with a sterile bandage

For use as an oral debriding agent (oral rinse):

adults and children 2 years of age and over:

mix with an equal amount of water

swish around in the mouth over the affected area for at least 1 minute and then spit out. Do not swallow.

use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

Children under 12 years should be supervised in the use of this product.

Children under 2 years of age: consult a doctor or dentist.

Other Information

Keep tightly closed and in a dark place at room temperature  Do not shake bottle. Hold away from face when opening.

Inactive Ingredients:

Purified water.

SPL UNCLASSIFIED SECTION

Topical Solution USP

FIRST AID ANTISEPTIC

+ Treats minor cuts and abrasions

+ Oral debriding agent

+ Use as a gargle or rinse

DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

New Life Products Inc.  Chicago, IL 60629
Watford WD24 7GN, UK  800-262-2326
www.newlifesanitizer.com

ISO 9001, 22716 and cGMP compliant

MADE IN USA

Packaging

INGREDIENTS AND APPEARANCE

NEW LIFE 3% HYDROGEN PEROXIDE FIRST AID ANTISEPTIC 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49681-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	3 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49681-016-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/05/2021
2	NDC: 49681-016-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/05/2021
3	NDC: 49681-016-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/05/2021

Labeler - New Life Products, Inc. (117815140)

Establishment
Name	Address	ID/FEI	Business Operations
New Life Products, Inc.		117815140	manufacture(49681-016)