HYDROGEN PEROXIDE solution

Hydrogen Peroxide by

Drug Labeling and Warnings

Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by Cariba International, Vi-Jon. 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 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 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 redess 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 coverd with a sterile bandage
• if bandaged, let dry first

Oral debriding agent: adults, children over 2 years of age:

• mix with an equal amount of water
• swish around in the mouth over the affected area for at least 1 minure, 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, doctor

Other information

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

Inactive ingredients

purified water

SPL UNCLASSIFIED SECTION

Distributed by: Cariba International

P.O. Box 1208

Safety Harbor, Florida 34695

MADE IN USA WITH US AND FOREIGN COMPONENTS

Principal Display Panel

CARIBA

HYDROGEN PEROXIDE TOPICAL SOLUTION USP

FIRST AID ANTISEPTIC, ORAL DEBRIDING AGENT

Square bottle uses less plastic than a similarly sized round bottle

Recyclable (if available in your area)

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: 67860-871
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: 67860-871-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/28/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/28/2016

Labeler - Cariba International (049354067)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(67860-871)