HYDROGEN PEROXIDE lotion

Hydrogen Peroxide by

Drug Labeling and Warnings

Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Vi-Jon Inc, Vi-Jon, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Do not use

in 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 affected area 1 to 3 times a day
irritation, pain or redness persists or worsens
swelling, rash, or fever develops
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
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 and at controlled room temperature.  Do not shake bottle.  Hold away from face when opening

Inactive ingredient

purified water

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313

PRINCIPAL DISPLAY PANEL

Do not use if printed seal under cap is broken or missing
NDC: 32706-871-43
LEADER
Hydrogen Peroxide Topical Solution USP
First Aid Antiseptic
Oral Debriding Agent
16 FL OZ (1 PT) 473 mL

871.001/871AA

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE 
hydrogen peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-871
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 kg  in 100 L

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-871-43	.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2012
2	NDC: 37205-871-45	.946 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2012
3	NDC: 37205-871-34	.237 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/12/2012

Labeler - Cardinal Health (097537435)

Registrant - Vi-Jon Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		790752542	manufacture(37205-871)