Label: PEROXYL MOUTH SORE MILD MINT- hydrogen peroxide rinse

  • NDC Code(s): 0126-0083-16, 0126-0083-22, 0126-0083-31, 0126-0083-70, view more
    0126-0083-99
  • Packager: Colgate Oral Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 1, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydrogen peroxide 1.5% (w/v)

  • Purposes

    Oral debriding agent/oral wound cleanser

  • Uses

    • 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
  • 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 half a capful (two teaspoons or 10 mL) 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 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
  • Inactive ingredients

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

  • Other Information

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

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    COLGATE-PALMOLIVE COMPANY
    New York, NY 10022

  • PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

    ALCOHOL FREE*

    Colgate®
    Oral Debriding Agent

    Peroxyl®

    Mouth Sore Rinse |
    1.5% Hydrogen
    Peroxide

    CLEANSES & PROMOTES HEALING
    OF MINOR ORAL WOUNDS

    HELPS PROMOTE HEALING OF:

    ✓
    ORAL SORES
    ✓
    IRRITATIONS
    ✓
    MOUTH BURNS

    MILD MINT

    16.9 FL OZ
    (1.05 PT)
    500 mL

    Helps Promote Healing

    P9933376

    PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    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)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBLUE (Light Blue Solution with the Smell of Mint) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0126-0083-16500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2009
    2NDC:0126-0083-99250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2015
    3NDC:0126-0083-7050 in 1 CARTON03/15/2017
    310 mL in 1 POUCH; Type 0: Not a Combination Product
    4NDC:0126-0083-31946 mL in 1 BOTTLE; Type 0: Not a Combination Product08/29/2020
    5NDC:0126-0083-221000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02201/01/2009
    Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!