FDA Label for Sore Mouth Cleanser
View Indications, Usage & Precautions
Sore Mouth Cleanser Product Label
The following document was submitted to the FDA by the labeler of this product Rite Aid. 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.
Active Ingredient
Hydrogen peroxide 150 mg/10mL
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 physician
- 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 glcol, poloxamer 338, polysorbate 20, flavor, sodium saccharin, blue 1
Disclaimer
This product is not manufactured or distributed by Colgate Oral Pharmaceuticals, distributor of Colgate Peroxyl Mouth Sore Rinse Alcohol-Free Mild Mint
Adverse Reactions
SATISFACTION GUARANTEE:
If you're not satisfied we'll happily refund your money.
DISTRIBUTED BY:
RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011
www.riteaid.com
Principal Display Panel
Sealed with printed neckband for your protection
Compare to Colgate Peroxy Mouth Sore Rinse Alcohol-Free Mild Mint
FREE FROM ALCOHOL FREE
PEROXIDE MOUTH RINSE
HYDROGEN PEROXIDE ORAL DEBRIDING AGENT
MINT
1.5% hydrogen peroxide cleans and helps relieve minor irritations
8 FL OZ (236 mL)
* Please review the disclaimer below.