DUOCARE CLINICAL ORAL RINSE- cetylpyridinium chloride mouthwash

DuoCare Clinical Oral Rinse by

Drug Labeling and Warnings

DuoCare Clinical Oral Rinse by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Cetylpyridinium Chloride 0.1%

Purpose

Antigingivitis/Antiplaque

Uses

• helps prevent and reduce plaque that leads to gingivitis and bleeding gums

Warnings

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.

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.

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, Inc., Northfield, IL 60093 USA. Made in the USA with U.S. and Foreign Components. 1-800-MEDLINE

Package Label

INGREDIENTS AND APPEARANCE

DUOCARE CLINICAL ORAL RINSE 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-030
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLOXAMER 407 (UNII: TUF2IVW3M2)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-030-13	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018
2	NDC: 53329-030-07	7 mL in 1 POUCH; Type 0: Not a Combination Product	11/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	11/01/2018

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Unette Corporation		011401882	pack(53329-030)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		117337220	manufacture(53329-030)