HYDROGEN PEROXIDE TOPICAL SOLUTION U.S.P- hydrogen peroxide solution

Hydrogen Peroxide Topical Solution U.S.P by

Drug Labeling and Warnings

Hydrogen Peroxide Topical Solution U.S.P by is a Otc medication manufactured, distributed, or labeled by Economy Polymers and Chemicals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredient

Hydrogen Peroxide 3%

Purpose

First Aid Antiseptic

USES

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

Warnings

For External Uses only, avoid swallowing

DO NOT USE

in the eyes or apply over large areas of the body longer than one week.

Stop use and ask doctor if:

condition persist or worsens, sore mouth symptoms do not improve in 7 days irritation pain or redenss persists or worsens swelling, rash of fever develops. Deep 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.

DIRECCTION FOR USE A FIRST AID ANTISEPTIC

Clean affected area. Apply small amount of product on affected area 1-3 times day. May be covered with a sterile bandage. If bandaged let dry first.

FOR USE AS AN ORAL RINSE AGENT

Adults and children 2 years of age and over: mix with an equal amount of water. Swish around mouth over the affected area for at least 1 minute and then spilt out. Do Not Swallow. Use up to 4 times daily or as directed by your dentist or doctor.

Other Information

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

Inactive Ingredient

USP Water

Package Labeling:

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE TOPICAL SOLUTION U.S.P 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74830-002
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: 74830-002-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2021

Labeler - Economy Polymers and Chemicals (008087603)

Establishment
Name	Address	ID/FEI	Business Operations
Economy Polymers and Chemicals		008087603	manufacture(74830-002)