PEROXYL MOUTH SORE MILD MINT- hydrogen peroxide rinse 
Colgate Oral Pharmaceuticals, Inc.

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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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

  • 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

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

PRINCIPAL DISPLAY PANEL - 50 Packet Carton
PEROXYL MOUTH SORE MILD MINT 
hydrogen peroxide rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0126-0083
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V) Hydrogen Peroxide15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Poloxamer 338 (UNII: F75JV2T505)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Product Characteristics
ColorBLUE (Light Blue Solution with the Smell of Mint) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0126-0083-7050 in 1 CARTON
110 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35601/01/2009
Labeler - Colgate Oral Pharmaceuticals, Inc. (055002195)

Revised: 9/2015
Document Id: 763f77be-3bac-4ae3-b00b-cd1f641c81f0
Set id: 818575ec-5136-4d4f-a0d4-51a7770499be
Version: 1
Effective Time: 20150908
 
Colgate Oral Pharmaceuticals, Inc.