HYDROGEN PEROXIDE- hydrogen peroxide solution

Hydrogen Peroxide by

Drug Labeling and Warnings

Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by Worldwide Sales & Distribution Corp., Steller Mercantile Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient
Hydrogen peroxide 3%

Purpose
First aid antiseptic
Oral debriding agent

INDICATIONS & USAGE

Uses

• first aid to help prevent the risk of infection in minor cuts, scrapes and burns
• aid in the removal of phlegm, mucus or other secretions associated with occasional sore mouth

WARNINGS

Warnings
For external use only

Do not use

• in the eyes or apply over large areas of the body
• more than one week

Consult a doctor before use if you have animal bites or serious burns, deep or punctured wounds

Stop use and ask a doctor if

• the condition persists or gets worse
• sore mouth symptoms do not improve in a week
• pain redness or irritation persists or if you develop fever, rash or swelling

Keep out of reach of children
If swallowed seek professional assistance or contact a poison control center immediately

DOSAGE & ADMINISTRATION

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
let dry first before using bandage

Oral debriding agent (oral rinse)
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 doctor or dentist

children under 2 years of age: consult a dentist or doctor
children under 12 years of age should be supervised in the use of this product

GENERAL PRECAUTIONS

Other information
Keep tightly closed in a dark place at controlled room temperature
Do not shake bottle. Keep away from face when opening

INACTIVE INGREDIENT

Inactive ingredient
Purified water

Package Label

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE  
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76384-007
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: 76384-007-01	.473 L in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/25/2011

Labeler - Worldwide Sales & Distribution Corp. (627014330)

Establishment
Name	Address	ID/FEI	Business Operations
Steller Mercantile Pvt. Ltd.		650493005	manufacture