ANTISEPTIC ORAL CLEANSER- hydrogern peroxide mouthwash 
OLD EAST MAIN CO.

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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Alcohol-Free Mint Peroxide Rinse
462.002/462.AA rev 1

Active ingredient 

Hydrogen Peroxide 1.5%w/v

Purpose

Oral debriding agent/Oral wound cleanser

Use

▪ aids in the removal of phlegm, 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, accidental injury, or other irritations of the mouth and gums
▪ for temporary use to cleanse canker sores
▪ assists in the removal of foreign material from minor oral wounds

Warnings

Do not use this product

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 redness 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, flavor, sodium saccharin, blue 1

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SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

DISRRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

principal display panel

Since 1903

Rexall

Alcohol-Free 

Peroxide Rinse

Oral debriding agent

Hydrogeben Peroxide

smoothing Mint

8 FL OZ (236 mL)

image description

ANTISEPTIC ORAL CLEANSER 
hydrogern peroxide mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-171
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE150 mg  in 100 L
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MENTHOL (UNII: L7T10EIP3A)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
POLOXAMER 338 (UNII: F75JV2T505)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-171-34.236 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/19/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/19/2009
Labeler - OLD EAST MAIN CO. (068331990)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55910-171)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(55910-171)

Revised: 9/2022
Document Id: cbc65148-95fd-4dc6-b01f-2b81ce7d3265
Set id: 7de2eae9-6429-48d3-969a-348cbbdbafa6
Version: 10
Effective Time: 20220923
 
OLD EAST MAIN CO.