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  5. Label Information: Peroxyl Mouth Sore Mild Mint

FDA Label for Peroxyl Mouth Sore Mild Mint

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSES
    4. USES
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. INACTIVE INGREDIENTS
    11. OTHER INFORMATION
    12. QUESTIONS?
    13. PRINCIPAL DISPLAY PANEL - 500 ML BOTTLE LABEL

Peroxyl Mouth Sore Mild Mint Product Label

The following document was submitted to the FDA by the labeler of this product Colgate Oral Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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:

* Please review the disclaimer below.