Hydrogen Peroxide

Hydrogen Peroxide

Drug Labeling and Warnings

Drug Details

k">

HYDROGEN PEROXIDE- hydrogen peroxide solution 
Duane Reade

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.

----------

Hydrogen Peroxide

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, 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 than 1 week

As 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 9oral 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

Questions?

Call 1-800-910-6674

Principal display Panel

Duane Reade

hydrogen peroxide topical solution USP

first aid antiseptic

oral debriding agent

for treatment of minor cuts and abrasions

for use as a gargle or rinse

Sealed with printed neckband for your protection

16 FL OZ (1 PT) 473 mL

image description

871.000/871AA

HYDROGEN PEROXIDE 
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67732-871
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: 67732-871-43.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/22/2009
2NDC: 67732-871-45.946 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/22/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/22/2009
Labeler - Duane Reade (011988995)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon790752542manufacture(67732-871)

Revised: 12/2018
 
Duane Reade


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.