HYDROGEN PEROXIDE solution

Hydrogen Peroxide by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Hydrogen peroxide (stabilized) 3%

purpose

First Aid Antiseptic

Oral debriding agent

Use

• 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 occassional 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 pucture 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 the product on the affected area 1 to 3 times a day
• may be covered with a sterile bandage
• if bandage, let dry first

Oral Debriding Agent: 

• adults, children over 2 years of age
• mix with equal amount of water
• swish around in the mouth over the affected area for at least 1 minute, then spit out
• use up to 4 times daily after meals and at bedtime
• children under 12 years of age should be supervised in the use
• 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

water

Disclaimer

2015 Cardinal Health.  All Rights Reserved

CARDINAL HEALTH and the Cardinal Health

LOGO are trademarks or registered trademarks of Cardinal Health.

450.000/450AA

Adverse reactions

Distributed by: Cardinal Health

Waukegan, IL 60085 USA

cardinalhealth.com 05/15

450.000/450AA

principal display panel

NDC: 63517-450-43

Hydrogen

Peroxide 3%

first aid antiseptic

oral debriding agent

DO NOT USE IF PACKAGE OPENED OR DAMAGED

TEMPERATURE LIMITATION 68°F - 77°F 20°C - 25°C

Not Made with Natural Rubber Latex

For Individual, Professional, and Hospital Use

Cat. AS-HPL16

Distributed by: Cardinal Health

Waukegan, IL 60085 USA

cardinalhealth.com 05/15

2015 Cardinal Health. All Rights Reserved.

CARDINAL HEALTH and the Cardinal Health

LOGO are trademarks of Cardinal Health.

CardinalHealth

16 FL OZ (1 PT) 473 mL

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63517-450
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: 63517-450-26	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2015
2	NDC: 63517-450-34	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2015
3	NDC: 63517-450-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2015

Labeler - Cardinal Health (961027315)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(63517-450)