Active Ingredient
Hydrogen peroxide 150 mg/10mL
Sore Mouth Cleanser Mouthwash
FDA Label NDC 41250-750
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer, Inc. for the product Sore Mouth Cleanser (NDC 41250-750). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral debriding agent/Oral wound cleanser
Uses
- aids in the removal of phlgem, mucus, or other secretions associated with occasional sore mouth
- for temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, acidental injury, or other irritations of the mouth and gums
- for temporary use to cleanse canker sores
- assists in the removal of foreign material from minor oral wounds
Warnings
For this product
Do Not Use
this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redenss persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly
When Using This Product
do not swallow
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 two teaspoons (10 mL) around the mouth 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 pysician
- children under 12 should be supervised in the use of the product
- children under 2 years of age: consult a dentist or doctor
Other Information
store at controlled room temperature 68-77°F (20-25°C)
Inactive Ingredients
water, sorbitol, propylene glycol, poloxamer 338, polysorbate 20, methyl salicylate, menthol, sodium saccharin, blue 1
Disclaimer
This product is not manufactured or distributed by Colgate Oral Pharmaceuticals, distributor of Colgate Peroxyl Mouth Sore Rinse
Adverse Reactions
Sealed With Printed Neckband For Your Protection
DIST. BY MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com
462.001/462AA
Principal Display Panel
Compare to
Colgate Peroxyl
Meijer
Soothing Mint
Sore Mouth
Peroxide Rinse
Hydrogen Peroxide
Alcohol-Free
Oral Debriding Agent
Cleans and helps
relieve minor mouth
and gum irritation
8 FL OZ (236 mL)
Image Description (Mm3)
Image Description (Mm3)
Image Description (Mm3)
* Please review the disclaimer below.
