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Sore Mouth Cleanser by Vi-Jon

Medically reviewed on May 11, 2018

Dosage form: mouthwash
Ingredients: HYDROGEN PEROXIDE 1588mg in 1mL
Labeler: Vi-Jon
NDC Code: 0869-0462

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.

Drug Facts

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

active ingredient

Hydrogen peroxide 150 mg/10mL

Purpose

Oral debriding agent/Oral wound cleanser

Uses
  • aids in the removal of phlgem, mucus, or other secretions associated with occasional sore mouth
  • for temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, acidental injury, or other irritations of the mouth and gums
  • for temporary use to clanse canker sores
  • assists in the removal of foreign material from minor oral wounds

Warnings

For this product

Do not use

this product for more than 7 days unless directed by a dentist or doctor.  If sore mouth symptoms do not improve in 7 days; if irritation, pain, or rednss persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly

When using this product

do not swallow

Keep out of reach of children

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Directions
  • adults and children 2 years of age and older: rinse two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out
  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician
  • children under 12 should be supervised in the use of the product
  • children under 2 years of age: consult a dentist or doctor

other information

store at controlled room temperature 68-77°F (20-25°C)

inactive ingredients

water, sorbitol, propylene glycol, poloxamer 338, polysorbate 20, methyl salicylate, menthol, sodium saccharin, blue 1

Disclaimer

This product is not manufactured or distributed by Colgate Oral Pharmaceuticals, distributor of Colgate Peroxyl Mouth Sore Rinse Mild Mint

Adverse Reactions

Manufactured by: Vi-Jon, Inc.,

St. Louis, MO 63114

Questions or Comments? 1-888-593-0593

Made in the USA

with US and foreign parts

462.001/462AA

principal display panel

mountain

falls

Compare to

Colgate

alcohol

free

cleans and

helps relieve

minor mouth

and gum

irritation

helps reduce

bacteria to

promote better

oral health

hydrogen

peroxide

mouth rinse

oral debriding agent

mint

8 FL OZ (326 mL)

SORE MOUTH CLEANSER 
hydrogen peroxide mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0462
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE1588 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
SORBITOL 
PROPYLENE GLYCOL 
POLOXAMER 338 
POLYSORBATE 20 
METHYL SALICYLATE 
MENTHOL 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:0869-0462-34236 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/02/2017
Labeler - Vi-Jon (790752542)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(0869-0462)

 
Vi-Jon

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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