FDA Label for Peroxy Shield Mouth Sore
View Indications, Usage & Precautions
Peroxy Shield Mouth Sore Product Label
The following document was submitted to the FDA by the labeler of this product Dental Technologies, 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.
Active Ingredient
Hydrogen peroxide 1.5% (w/w)
Purpose(S)
Oral debriding agent/oral wound cleaner
Uses
- For temporary use to cleanse canker sores and 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 your dentist or physician.
When using this product, do not swallow.
Stop use and ask your doctor if:
- Sore mouth symptoms do not improve within 7 days
- Irritation, pain, or redness persists or worsens
- Swelling, rash, or fever develops
- Children under 12 years of age: consult a dentist of physician.
- Children under 12 years of age should be supervised in the use of the product.
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
- For adults and children under 2 years of age or older: rinse one pump (15mL) around in the mouth over the 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.
Other Information
- Store at controlled room temperature, 20-25°C (68-77°F) and away from direct sunlight.
- For your protection, do not use if tamper evident seal under the cap is damaged or missing.
Inactive Ingredients
FD&C Blue #1, Menthol, Methyl Salicylate, Poloxamer 407, Polysorbate 20, Propylene Glycol, Sodium Saccharin, Sorbitol, Sucralose, Water
Questions Or Comments?
Call 1-800-835-0885
Principal Display Panel
ALCOHOL FREE
PEROXY SHIELD™
1.5% HYDROGEN PEROXIDE
MOUTH SORE RINSE
HELPS PROMOTE
A CLEANER MOUTH & HEALING OF
- ORAL SORES
- IRRITATIONS
- MOUTH BURNS
MINT FLAVOR
REF. 035-0101-002
63.0 FL. OZ. (1863 mL)
* Please review the disclaimer below.