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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Rexall  462   462.002/462.AA rev 1

Active ingredient (in each 10 mL)

Hydrogen Peroxide 150mg

Purpose

Oral debriding agent/Oral wound cleanser

Use

oral debriding agent/oral wound cleanser for temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums such as mouth burns, cheek bites and toothbrush abrasions

Warnings

Do not use this product

for more than 7 days unless directed by a dentist or physician.

When using this product,

do not swallow

Stop use and ask a doctor if

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

Directions

•rinse half a capful (two teaspoons or 10 mL mark on cap) around in mouth over affected area 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 years of age should be supervised in the use of the product
•children under 2 years of age: consult a dentist or physician

Other information

•store at controlled room temperature  20-25⁰ C (68-77⁰F)

Inactive ingredients

water, sorbitol, propylene glycol, poloxamer 338, polysorbate 20, flavor, sodium saccharin, blue 1

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

DISRRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% SATISFACTION GUARANTEED (888)- 309-9030

principal display panel

Rexall

Antiseptic Oral Cleanser Hydrogen Peroxide

  • Promotes healing of oral irritations
  • Oral debriding agent
  • Great tasting original flavor

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)

Revised: 7/2021
 
OLD EAST MAIN CO.