HYDROGEN PEROXIDE- hydrogen peroxide solution 
United Natural Foods, Inc. dba UNFI

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.

----------

3% Hydrogen Peroxide
871.001/871AA  

Active ingredient

 Hydrogen peroxide (stabilized) 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, mucous, or other secretions associated with occasional sore mouth

Warnings

For external use only

Do not use

Askd a doctor before use if you have

deep or puncture wounds, animal bites or serious burns

Stop use and ask a doctor if

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 to 3 times a day
•may be covered with a sterile bandage
•if bandaged, let dry first

Oral Debriding agent: adults and children 2 years of age and over:
• mix with 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 information

keep tightly closed and at controlled room temperature.  Do not shake bottle.  Hold away from face when opening.

Inactive ingredient

purified water

Distributed by UNFI, Providence, RI 02908 USA

855-423-2630

Principal Panel Display

NDC 41163-871-43

EQUALINE

3% USP

hydrogen peroxide topical solution

Do not use if printed seal under cap is broken or missing

16 FL OZ (1 PT) 473 mL

image description

HYDROGEN PEROXIDE 
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-871
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:41163-871-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/14/2005
2NDC:41163-871-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/14/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/14/2005
Labeler - United Natural Foods, Inc. dba UNFI (943556183)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi -Jon, LLC790752542manufacture(41163-871)
Establishment
NameAddressID/FEIBusiness Operations
Vi -Jon, LLC088520668manufacture(41163-871)

Revised: 5/2023
Document Id: 8a28bb65-c029-41de-a7ae-d071fe471d54
Set id: 8a44aa29-58d6-4971-b572-4579f03ed227
Version: 17
Effective Time: 20230510
 
United Natural Foods, Inc. dba UNFI