FDA Label for Prevention Mouth Rinse
View Indications, Usage & Precautions
Prevention Mouth Rinse Product Label
The following document was submitted to the FDA by the labeler of this product Prevention Health Sciences, 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.
Otc - Active Ingredient
Active ingredient
Hydrogen peroxide 1.5%
Otc - Purpose
Purpose
Oral debriding agent / Antiseptic
Indications & Usage
Uses
- first aid to help reduce the risk of infection in minor cuts and scrapes caused by
- dentures
- dental procedures
- orthodontic appliances
- accidental injury
- aids in the removal of phlegm, mucus or other secretions associated with occasional sore mouth
- for temporary use to cleanse canker sores, minor wounds and gum irritation
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 years of age should be supervised in the use of product.
- children under 2 years of age: consult a dentist or doctor.
Storage And Handling
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 water, glycerin, poloxamer 407, sodium lauryl sulfate, disodium EDTA, Mentha piperita (peppermint) oil, sodium citrate, sodium saccharin, citric acid, zinc chloride, menthol
Other
Questions? (800) 473-1205
Manufactured by:
Prevention Health Sciences, Inc.
Raleigh, IL 62977
Package Label.Principal Display Panel
ALCOHOL FREE
PREVENTION™ MOUTH RINSE
Formulated for MOUTH SORE RELIEF
Oral Antiseptic for Healing of Common Mouth Sores
- CANKER SORES
- IRRITATION FROM BRACES
- MINOR MOUTH INJURIES
Soothing Mint
NET. 16 FL OZ (1 PT) 473 ML
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