HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)
Available from:
MEIJER, INC.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
first aid antiseptic/oral debriding agent - 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
Authorization status:
OTC monograph not final
Authorization number:
41250-268-32

HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid

MEIJER, INC.

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.

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Drug Facts

Active ingredient

Hydrogen peroxide 3%

Purpos e

first aid antiseptic/oral debriding agent

Us es

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 a Poison Control Center (1-800-222-1222) right away.

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

purified water

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Princiapl Display Panel

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

hydrogen peroxide 3%

TOPICAL SOLUTION U.S.P.

First Aid Antiseptic

Oral Debriding Agent

For Treatment of Minor Cuts and Abrasions

FL OZ (mL)

DIST. BY MEIJER

DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

Package Label

MEIJER Hydrog en Peroxide 3%

HYDROGEN PEROXIDE 3 PERCENT

hydrogen peroxide liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -26 8

Route of Administration

TOPICAL

MEIJER, INC.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V) (HYDROGEN PEROXIDE -

UNII:BBX0 6 0 AN9 V)

HYDROGEN

PEROXIDE

3 mL

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:41250 -26 8 -

9 46 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 6 /30 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part356

0 6 /30 /20 19

Labeler -

MEIJER, INC. (006959555)

Revised: 7/2019

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