EVAXO 3% HYDROGEN PEROXIDE- hydrogen peroxide liquid

EVAXO 3% Hydrogen Peroxide by

Drug Labeling and Warnings

EVAXO 3% Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by Evaxo International Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Hydrogen peroxide 3%

Purpose

first aid antiseptic/ oral debriding agent

INDICATIONS & USAGE

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.

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 or redness persists or worsens.

Keep out of reach of children. If swallowed, get medical help or contact poison control center right away.

DOSAGE & ADMINISTRATION

Directions For use as a first aid antiseptic: *Clean affected area. *if bandaged, let dry first. *apply small amount of product on affected area 1-3 times a day. *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 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 dentist or doctor.

Other information

*Keep tightly closed and in a dark place at room temperature.

*Do not shake bottle. Hold away from face when opening.

INACTIVE INGREDIENT

Inactive ingredient purified water

SPL UNCLASSIFIED SECTION

Antiseptic

* For treatment of minor cuts and abrasions.

* Oral debriding agent.

* Use as a gargle or rinse.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY: EVAXO INTERNATIONAL INC.

Tampa, FI 33619

All rights reserved. Made in U.S.A

THE GREEN SOURCES

Exp. 5/2023

Packaging

INGREDIENTS AND APPEARANCE

EVAXO 3% HYDROGEN PEROXIDE 
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78376-234
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	30 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78376-234-32	946.6 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2020

Labeler - Evaxo International Inc (003464270)

Establishment
Name	Address	ID/FEI	Business Operations
Evaxo International Inc		003464270	manufacture(78376-234)