Peroxyl Mouth Sore Mild Mint Rinse
FDA Label NDC 0126-0083

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Colgate Oral Pharmaceuticals Inc. for the product Peroxyl Mouth Sore Mild Mint (NDC 0126-0083). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purposes, uses, otc - do not use, otc - when using, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

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

Otc - Do Not Use

Do not use this product for more than 7 days unless directed by a dentist or physician.

Otc - When Using

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

Otc - Keep Out Of Reach Of Children

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

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)

    Principal Display Panel (500 mL Bottle Label)

* Please review the disclaimer below.