MEDICHOICE OF HYDROGEN PEROXIDE 3 10 VOLUME- 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:
Owens & Minor Distribution, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
• first aid to help prevent the risk of infection in minor cuts, scrapes and burns • aids in the removal of phlegm, mucous, or other secretions associated with occasional sore mouth
Authorization status:
OTC monograph not final
Authorization number:
39892-0700-1, 39892-0700-2, 39892-0700-3

MEDICHOICE OF HYDROGEN PEROXIDE 3 10 VOLUME- hydrogen peroxide liquid

Owens & Minor Distribution, 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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MediChoice Solution of Hydrogen Peroxide 3% USP 10 Volume

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, mucous, 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 1 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

the condition persists or gets worse

sore mouth symptoms do not improve in 7 days

irritation, pain, or redness persists or worsens swelling, rash, or fever develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

First aid antiseptic:

clean the affected area

apply a small amount of product on the area 1 to 3 times daily

may be covered with a sterile bandage

if bandaged, let dry first 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

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

children under 12 years of age 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 in a cool dark place. Do not shake bottle. Hold away from face when opening.

Inactive ingredient

purified water

MediChoice Solution of Hydrogen Peroxide 3% USP 10 Volume 4 Fl.Oz./l18mL (39892-0700-1)

MediChoice Solution of Hydrogen Peroxide 3% USP 10 Volume 8 Fl.Oz/237mL (39892-0700-2)

MediChoice Solution of Hydrogen Peroxide 3% USP 10 Volume 16 Fl.Oz./473mL (39892-0700-

3)

MEDICHOICE OF HYDROGEN PEROXIDE 3 10 VOLUME

hydrogen peroxide liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:39 8 9 2-0 70 0

Route of Administration

TOPICAL

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

30 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Owens & Minor Distribution, Inc.

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:39 8 9 2-0 70 0 -1

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/20 /20 19

2

NDC:39 8 9 2-0 70 0 -2

237 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/20 /20 19

3

NDC:39 8 9 2-0 70 0 -3

473 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/20 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 3/20 /20 19

Labeler -

Owens & Minor Distribution, Inc. (847412269)

Revised: 12/2019

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