Otc - Active Ingredient
Active ingredient
Hydrogen peroxide 1.4%
Prevention Mouth Sore Rinse Liquid
FDA Label NDC 69951-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prevention Health Sciences, Inc. for the product Prevention Mouth Sore Rinse (NDC 69951-004). 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 otc - active ingredient, otc - purpose, indications & usage, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Oral debriding agent / Oral wound cleanser
Indications & Usage
Uses
- Aids in the removal of phlegm, 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, accidental injury, or other irritations of the mouth and gums.
- For temporary use to cleanse canker sores.
Otc - Do Not Use
Do not use for more than 7 days unless directed by a dentist or doctor
Otc - Stop Use
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.
Dosage & Administration
Directions
- adults and children 2 years of age and older: swish one capful (10 ml) around in mouth over affected area for at least one minute and then spit out
- use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
- children under 12 should be supervised in the use of product.
- children under 2 years of age: consult a dentist or doctor.
Other Information
- keep away from heat or direct sunlight
- Do not use if safey seal under cap is broken or missing
Inactive Ingredient
Inactive ingredients Citric Acid, Disodium EDTA, Glycerin, Menthol, Peppermint Oil, Poloxamer 407, Polysorbate 20, Purified Water, Sodium Citrate, Sucralose, Zinc Chloride
Otc - Questions
Questions? call (800) 473-1205
Other
Formulated and Distribured by:
Prevention Health Sciences, Inc.
Raleigh, IL 62977
800-473-1205
PHS Brands
Package Label.Principal Display Panel
ALCOHOL FREE
PREVENTION™ MOUTH RINSE
Formulated for MOUTH SORE RELIEF
Oral Wound Cleanser For Common Mouth Sores
- CANKER SORES
- IRRITATION FROM BRACES
- MINOR MOUTH INJURIES
Soothing Mint
NET. 16 FL OZ (1 PT) 473 ML
* Please review the disclaimer below.
