CloSYS HYDROGEN PEROXIDE ROWPAR PHARMACEUTICALS, INC. FDA Approved Uses For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums. Assist in the removal of foreign material from minor oral wounds.
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Substance Hydrogen Peroxide
Route
ORAL
Applications
M022

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Hydrogen Peroxide 1.5% (w/v)
Inactive Ingredients
Inactive ingredients water polypropylene glycol flavors polysorbate 20 polysorbate 80 sucralose disodium EDTA menthol citric acid
Strengths
1.5 %
Quantities
473 ml
Treats Conditions
Uses For Temporary Use To Cleanse Canker Sores And Minor Wounds Or Minor Gum Inflammation Resulting From Dental Procedures Dentures Orthodontic Appliances Accidental Injury Or Other Irritations Of The Mouth And Gums Assist In The Removal Of Foreign Material From Minor Oral Wounds

Identifiers & Packaging

Container Type UNKNOWN
UPC
0647692000125
UNII
BBX060AN9V
Packaging

Packaging A CLEANER MOUTH A HEALTHIER YOU ® CLoSYS ® Oral Debriding Agent MOUTH SORES SENSITIVE MOUTH RINSE PROMOTES HEALING HELPS CLEANSE & PROMOTE HEALING OF ORAL SORES, MOUTH BURNS & IRRITATION For Canker Sores, Cheek Bites, Irritation from Dentures or Braces, Gum Irritation Non Burning, Alcohol-Free Formula Gentle Mint 16 fl oz (473mL) 52516-75 Distributed by: Rowpar Pharmaceuticals, Inc., Bridgewater, NJ 08807 1 (800) 643-3337 closys.com 52516-76

Package Descriptions
  • Packaging A CLEANER MOUTH A HEALTHIER YOU ® CLoSYS ® Oral Debriding Agent MOUTH SORES SENSITIVE MOUTH RINSE PROMOTES HEALING HELPS CLEANSE & PROMOTE HEALING OF ORAL SORES, MOUTH BURNS & IRRITATION For Canker Sores, Cheek Bites, Irritation from Dentures or Braces, Gum Irritation Non Burning, Alcohol-Free Formula Gentle Mint 16 fl oz (473mL) 52516-75 Distributed by: Rowpar Pharmaceuticals, Inc., Bridgewater, NJ 08807 1 (800) 643-3337 closys.com 52516-76

Overview

Uses For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums. Assist in the removal of foreign material from minor oral wounds.

Indications & Usage

Uses For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums. Assist in the removal of foreign material from minor oral wounds.

Dosage & Administration

Directions Adults and children 12 years of age and older Use 10 mL (two teaspoons) around in the mouth over affected areas for at least 1 minute and spit out Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician Children 6 years to under 12 years of age: supervise use Children under 6 years of age: do not use

Warnings & Precautions
Warnings
Purpose

Purpose Oral debriding agent Oral wound cleanser

Keep Out of Reach of Children

Do not use this product for more than 7 days unless directed by a dentist, or physician. When using this product , do not swallow. 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. 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.

Questions

Questions or comments? call 1-800-643-3337


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