Label: EVAXO 3% HYDROGEN PEROXIDE- hydrogen peroxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 78376-234-32 - Packager: Evaxo International Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 1, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- INDICATIONS & USAGE
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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.
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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
- INACTIVE INGREDIENT
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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
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INGREDIENTS AND APPEARANCE
EVAXO 3% HYDROGEN PEROXIDE
hydrogen peroxide liquidProduct 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)