HYDROGEN PEROXIDE  - hydrogen peroxide lotion 
Cardinal Health

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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Active Ingredients
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 eyes or apply over large areas of the body
•longer than 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
•irritation, pain or redness persists or worsens
•swelling, rash, or fever develops
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
•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 CARDINAL HEALTH, DUBLIN, OHIO 43017
www.myleader.com  1-800-200-6313

Do not use if printed seal under
cap is broken or missing
NDC 32706-871-43
LEADER
Hydrogen
Peroxide
Topical Solution USP
First Aid Antiseptic
Oral Debriding Agent
16 FL OZ (1 PT) 473 mL
image of principal display panel

HYDROGEN PEROXIDE 
hydrogen peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-871
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE3 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:37205-871-43.473 L in 1 BOTTLE, PLASTICNone
2NDC:37205-871-45.946 L in 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/12/2012

Labeler - Cardinal Health (097537435)
Registrant - Vi-Jon Inc (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon, Inc790752542manufacture

Revised: 05/2012 Cardinal Health