HYDROGEN PEROXIDE liquid

HYDROGEN PEROXIDE by

Drug Labeling and Warnings

HYDROGEN PEROXIDE by is a Otc medication manufactured, distributed, or labeled by DEGASA SA DE CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrogen Peroxide (stabilized) 3%

Purpose

First Aid Antiseptic Oral debriding agent

Inactive Ingredients:

Purified water

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 ocassional 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.

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.

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

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 o 3 times a day

√ May be covered 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 minute, and 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 form face when opening.

Question or comments?

Call 956 728-8899

Package Labeling:

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE 
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67326-354
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	0.3 mL  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67326-354-01	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/15/2020

Labeler - DEGASA SA DE CV (812771980)

Establishment
Name	Address	ID/FEI	Business Operations
DEGASA SA DE CV		812771980	manufacture(67326-354)