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PEROXYL MOUTH SORE MILD MINT by Colgate Oral Pharmaceuticals, Inc.

Medically reviewed on September 10, 2018

Dosage form: rinse
Ingredients: Hydrogen Peroxide 15mg in 1mL
Labeler: Colgate Oral Pharmaceuticals, Inc.
NDC Code: 0126-0083

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.

PEROXYL® MOUTH SORE RINSE MILD MINT

Drug Facts

Active ingredient (in each 10 mL)

Hydrogen peroxide 150 mg

Purpose

oral debriding agent

Use

oral debriding agent/oral wound cleanser for temporary use to cleanse canker sores and minor wounds or minor gum inf ammation 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 within 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
  • adults and children 2 years of age and older: rinse contents of this package (two teaspoons) around in the 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 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 20-25° C (68-77° F)

Inactive ingredients

water, sorbitol, propylene glycol, poloxamer 338, polysorbate 20, methyl salicylate, menthol, sodium saccharin, FD&C blue no.1

Questions?

1-800-962-2345

PRINCIPAL DISPLAY PANEL - 50 Packet Carton

Colgate®

Peroxyl®

MOUTH SORE
RINSE
ALCOHOL-FREE

1.5% Hydrogen Peroxide

MILD MINT

50 Unit Dose Packets 0.34 FL OZ (10 mL) Each
TOTAL 17 FL OZ (1.06 PT) 502 mL

PEROXYL MOUTH SORE MILD MINT 
hydrogen peroxide rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0126-0083
Route of AdministrationBUCCALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrogen Peroxide (Hydrogen Peroxide) Hydrogen Peroxide15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Sorbitol 
Propylene Glycol 
Poloxamer 338 
FD&C BLUE NO. 1 
Polysorbate 20 
Saccharin Sodium 
Product Characteristics
ColorBLUE (Light Blue Solution with the Smell of Mint) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0126-0083-7050 POUCH in 1 CARTON
110 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35601/01/2009
Labeler - Colgate Oral Pharmaceuticals, Inc. (055002195)

 
Colgate Oral Pharmaceuticals, Inc.

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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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