Active Ingredient
Hydrogen peroxide 1.5% (w/w)
Peroxy Shield Mouth Sore Rinse
FDA Label NDC 55346-3501
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dental Technologies, Inc. for the product Peroxy Shield Mouth Sore (NDC 55346-3501). 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(s), uses, warnings, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
