HYDROGEN PEROXIDE solution

Hydrogen Peroxide by

Drug Labeling and Warnings

Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by Supervalu, Inc, Vi-Jon, Vi -Jon. 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, mucous, or other secretions associated with occasional sore mouth

Warnings

For external use only

Do not use

• in the eyes or apply over large ares of the body
• longer than 1 week

Askd 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
may be covered with a sterile bandage
if bandaged, let dry first

Oral Debriding agent: adults and children 2 years of age and over:
mix with 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 and at controlled room temperature.  Do not shake bottle.  Hold away from face when opening.

Inactive ingredient

purified water

SPL UNCLASSIFIED SECTION

Distributed by SUPERVALU, INC.
EDEN PRARIE, MN 55344
CONTACT US AT 1-877-932-7948
www.supervalu-ourownbrands.com

Principal display panel

NDC: 41163-871-43

EQUALINE

3% USP

hydrogen peroxide topical solution

• first aid antseptic
• oral debriding agent
• for treatment of minor cuts & abrasions
• for use as a gargle

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

16 FL OZ (1 PT) 473 mL

871.001/871AA

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-871
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: 41163-871-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/14/2005
2	NDC: 41163-871-45	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/14/2005

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/14/2005

Labeler - Supervalu, Inc (006961411)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi -Jon		790752542	manufacture(41163-871)