HYDROGEN PEROXIDE solution

Hydrogen Peroxide by

Drug Labeling and Warnings

Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by Delon Laboratories (1990) Ltd, Laboratoires Delon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Hydrogen peroxide 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 unless directed by a doctor or dentist

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 this product on the area 1 to 3 times daily
• 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 older:
• mix with an equal amount of warm 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 in a cool dark place
• do not shake bottle
• hold away from face when opening

Inactive ingredient

purified water

Delon Hydrogen Peroxide 3%

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61734-010
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 mL  in 100 mL

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

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61734-010-01	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/08/2014
2	NDC: 61734-010-02	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/08/2014	12/07/2014
3	NDC: 61734-010-03	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/08/2014	12/04/2014
4	NDC: 61734-010-04	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/08/2014	12/04/2014
5	NDC: 61734-010-05	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/08/2014	12/04/2014
6	NDC: 61734-010-06	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/08/2014	12/04/2014
7	NDC: 61734-010-07	175 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/08/2014	10/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/08/2014

Labeler - Delon Laboratories (1990) Ltd (248364184)

Establishment
Name	Address	ID/FEI	Business Operations
Delon Laboratories (1990) Ltd		243387722	label(61734-010) , manufacture(61734-010) , pack(61734-010)