Hydrogen Peroxide

Hydrogen Peroxide

Drug Labeling and Warnings

Drug Details

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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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Hydrogen Peroxide

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

Market Basket
MORE FOR YOUR DOLLAR
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)
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
16 FL OZ (1 PT) (473 mL)

image of principal display panel

871.001/871AA

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 PEROXIDE.3 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53942-871-43.473 L 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 (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon790752542manufacture(53942-871)

Revised: 12/2018
 
Demoulas Super Markets, Inc


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