Closys Mouth Sores Oral Rinse

Closys Mouth Sores Oral Rinse
SPL v2
SPL
SPL Set ID 299fc7b1-af6d-4bf9-810f-d35283423fe2
Route
ORAL
Published
Effective Date 2025-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (1.5 g)
Inactive Ingredients
Water Propylene Glycol Polysorbate 20 Polysorbate 80 Sucralose Edetate Disodium Menthol, Unspecified Form Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-27

Description

Hydrogen Peroxide 1.5% (w/v)

Purpose

Oral debriding agent Oral wound cleanser


Medication Information

Purpose

Oral debriding agent

Oral wound cleanser

Description

Hydrogen Peroxide 1.5% (w/v)

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.
Section 42229-5

Section 50565-1

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.

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

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

Active Ingredient

Hydrogen Peroxide 1.5% (w/v)

Other Information
  • Do not use if safety seal is broken or missing
  • Cap tightly
  • Keep away from direct sunlight

  • Store at room temperature, 68 to 77°F (20 to 25°C)

Inactive Ingredients

water, polypropylene glycol, flavors, polysorbate 20, polysorbate 80, sucralose, disodium EDTA, menthol, citric acid

Questions Or Comments?

call 1-800-643-3337


Structured Label Content

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.
Section 42229-5 (42229-5)

Section 50565-1 (50565-1)

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.

Purpose

Oral debriding agent

Oral wound cleanser

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

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

Active Ingredient (Active ingredient)

Hydrogen Peroxide 1.5% (w/v)

Other Information
  • Do not use if safety seal is broken or missing
  • Cap tightly
  • Keep away from direct sunlight

  • Store at room temperature, 68 to 77°F (20 to 25°C)

Inactive Ingredients (Inactive ingredients)

water, polypropylene glycol, flavors, polysorbate 20, polysorbate 80, sucralose, disodium EDTA, menthol, citric acid

Questions Or Comments? (Questions or comments?)

call 1-800-643-3337


Advanced Ingredient Data


Raw Label Data

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