HYDROGEN PEROXIDE- hydrogen peroxide solution 
Demoulas Super Markets, Inc

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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3% Hydrogen Peroxide
871.001/871AA 

Active ingredient

Hydrogen peroxide (stabilized) 3%

Purpose

First aid antiseptic
Oral debriding agent

Use

• first aid to help prevent the rise 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 then 1 week

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 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 (oral rinse): adults and children 2 years of age and over:
•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 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 DEMOULAS SUPER MARKETS, INC.
875 East Street, Tewksbury, MA 01876

principal display panel

"MORE FOR YOUR DOLLAR"

Market Basket

HYDROGEN PEROXIDE

TOPICAL SOLUTION USP

FIRST AID ANTISEPTIC

ORAL DEBRIDING AGENT

Square bottle uses less plastic than a similarly sized round bottle

Recyclable (if available in your area)

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

16 FL OZ (1PT) 473 mL

image description

HYDROGEN PEROXIDE 
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-871
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:53942-871-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1989
2NDC:53942-871-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1989
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/15/1989
Labeler - Demoulas Super Markets, Inc (007869647)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(53942-871)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC088520668manufacture(53942-871)

Revised: 1/2023
Document Id: bd5236c5-774f-44c8-9a60-8c7527481411
Set id: 615422e9-e1cf-43bc-bd22-532c0d90858f
Version: 13
Effective Time: 20230126
 
Demoulas Super Markets, Inc