030 Duocare™ Clinical Oral Rinse

030 Duocare™ Clinical Oral Rinse
SPL v8
SPL
SPL Set ID 98e61cd5-7e29-7066-e053-2a95a90afa21
Route
DENTAL
Published
Effective Date 2018-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (1 mg)
Inactive Ingredients
Sucralose Citric Acid Monohydrate Poloxamer 407 Glycerin Methyl Salicylate Sodium Citrate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-01

Description

Cetylpyridinium Chloride 0.1%

Purpose

Antigingivitis/Antiplaque


Medication Information

Purpose

Antigingivitis/Antiplaque

Description

Cetylpyridinium Chloride 0.1%

Uses
  • helps prevent and reduce plaque that leads to gingivitis and bleeding gums
Section 43683-2
  • Dosage and Administration
Directions
  • adults and children 12 years of age and older: swish 7 ml of rinse between your teeth for approximately one minute and then spit out. Do not swallow the rinse.
  • Use up to 4 times daily or as directed by dentist or doctor.
  • children 6 years to under 12 years of age: supervise use.
  • children under 6 years of age: consult a dentist or a doctor.
Package Label

Active Ingredient

Cetylpyridinium Chloride 0.1%

Other Information
  • avoid excessive heat and protect from freezing
  • shield from direct sunlight
Inactive Ingredients

citric acid, glycerin, methyl salicylate, poloxamer 407, purified water, sodium citrate, sucralose, supermint

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in the USA with U.S. and Foreign Components.

www.medline.com

1-800-MEDLINE (633-5463)

REF: MDS096316

V1 RC22ANO

Stop Use and Ask A Doctor If
  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasingspacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
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.


Structured Label Content

Uses
  • helps prevent and reduce plaque that leads to gingivitis and bleeding gums
Section 43683-2 (43683-2)
  • Dosage and Administration
Purpose

Antigingivitis/Antiplaque

Directions
  • adults and children 12 years of age and older: swish 7 ml of rinse between your teeth for approximately one minute and then spit out. Do not swallow the rinse.
  • Use up to 4 times daily or as directed by dentist or doctor.
  • children 6 years to under 12 years of age: supervise use.
  • children under 6 years of age: consult a dentist or a doctor.
Package Label

Active Ingredient (Active ingredient)

Cetylpyridinium Chloride 0.1%

Other Information (Other information)
  • avoid excessive heat and protect from freezing
  • shield from direct sunlight
Inactive Ingredients (Inactive ingredients)

citric acid, glycerin, methyl salicylate, poloxamer 407, purified water, sodium citrate, sucralose, supermint

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in the USA with U.S. and Foreign Components.

www.medline.com

1-800-MEDLINE (633-5463)

REF: MDS096316

V1 RC22ANO

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasingspacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
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.


Advanced Ingredient Data


Raw Label Data

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