HYDROGEN PEROXIDE solution

Hydrogen Peroxide by

Drug Labeling and Warnings

Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by Pharmacy Value Alliance LLC, 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

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 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 affected 1 to 3 times a day
• may be covered with sterile bandage
• if bandaged, 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 uner 12 years of age should be supervused in the use
• children under 2 years of age: consult a dentist, doctor

Other information

keep tightly closed and a controlled room temperature.  Do not shake bottle.  Hold away from face when opening.

Inactive ingredient

purified water

Questions?

1-888-593-0593

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

Pharmacy Value Alliance LLC

407 East Lancaster Avenue,

Wayne. PA 19087  www.emersongroup.com

Principal Display Panel

Premier Value

Hydrogen Peroxide topical solution USP

first aid antiseptic

oral debriding agent

Do not use if printed seal under cap is broken or missing

32 FL OZ (1 QT) 946 mL

871.001/871AA

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-871
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	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: 68016-871-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/13/2003
2	NDC: 68016-871-45	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/13/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/13/2003

Labeler - Pharmacy Value Alliance LLC (101668460)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(68016-871)