HYDROGEN PEROXIDE TOPICAL SOLUTION U.S.P- hydrogen peroxide solution 
Economy Polymers and Chemicals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hydrogen Peroxide Topical Solution U.S.P.

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:

Label

HYDROGEN PEROXIDE TOPICAL SOLUTION U.S.P 
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74830-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74830-002-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2021
Labeler - Economy Polymers and Chemicals (008087603)
Establishment
NameAddressID/FEIBusiness Operations
Economy Polymers and Chemicals008087603manufacture(74830-002)

Revised: 3/2021
Document Id: bccc7855-92fa-f45a-e053-2a95a90a00cf
Set id: 25d77750-8904-4f5f-85ba-8efe9ba9d3e3
Version: 1
Effective Time: 20210305
 
Economy Polymers and Chemicals