HYDROGEN PEROXIDE - hydrogen peroxide solution 
Vi-Jon

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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Drug Facts

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: 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: Vi-Jon
One Swan Drive, Smyrna, TN 37167

Swan
HYDROGEN
PEROXIDE
Topical Solution USP
•First Aid Antiseptic
 Oral Debriding Agent
•For Treatment of Minor
 Cuts + Abrasions
•For Use As a Gargle or Rinse
Square bottle uses less plastic
than a similarly sized 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

HYDROGEN PEROXIDE 
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0869-0871
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE.3 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0869-0871-43.473 L in 1 BOTTLE, PLASTIC
2NDC:0869-0871-45.946 L in 1 BOTTLE, PLASTIC
3NDC:0869-0871-26.118 L in 1 BOTTLE, PLASTIC
4NDC:0869-0871-34.237 L in 1 BOTTLE, PLASTIC
5NDC:0869-0871-083.79 L in 1 BOTTLE, PLASTIC
6NDC:0869-0871-38.296 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/15/1989
Labeler - Vi-Jon (790752542)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi -Jon790752542manufacture

Revised: 1/2011
Document Id: b802a19f-9127-433c-889a-fe24882a4fb9
Set id: e0a07631-6770-48b3-bf7b-19f3f3965cd9
Version: 1
Effective Time: 20110101
 
Vi-Jon