DOP HYDROGEN PEROXIDE 3%- hydrogen peroxide liquid

DOP Hydrogen Peroxide 3% by

Drug Labeling and Warnings

DOP Hydrogen Peroxide 3% by is a Otc medication manufactured, distributed, or labeled by Omega & Delta Co. Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Hydrogen peroxide (stabilized) 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 aids 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 do not use longer than 1 week

Ask a doctor before use if you have deep or punctured 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

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 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 (oral rinse):

adults and children 2 years of age and over:

• mix with an 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 SAFETY INFORMATION

Other Information  Keep thightly closed and a controlled room temperature.  Do not

shake bottle.  Hold away from face when opening.

INACTIVE INGREDIENT

Inactive Ingredient  Purified Water.

SPL UNCLASSIFIED SECTION

Distributed by:

Omega & Delta Co., Inc.

Carolina, P.R. 00984

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOP HYDROGEN PEROXIDE 3% 
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51048-040
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 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51048-040-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2000
2	NDC: 51048-040-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2006
3	NDC: 51048-040-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2000

Labeler - Omega & Delta Co. Inc. (090317793)

Establishment
Name	Address	ID/FEI	Business Operations
Omega & Delta Co. Inc.		090317793	manufacture(51048-040)