DUOCARE CLINICAL ORAL RINSE- cetylpyridinium chloride mouthwash mouthwash

DuoCare Clinical Oral Rinse by

Drug Labeling and Warnings

DuoCare Clinical Oral Rinse by is a Otc medication manufactured, distributed, or labeled by IIMED MEDICAL MEXICANA S DE RL DE CV, Team Technologies. 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 increasing spacing between the teeth. These may be the signs 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

Label

INGREDIENTS AND APPEARANCE

DUOCARE CLINICAL ORAL RINSE 
cetylpyridinium chloride mouthwash mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83062-030(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
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POLOXAMER 407 (UNII: TUF2IVW3M2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83062-030-13	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/06/2023
2	NDC: 83062-030-07	7 mL in 1 POUCH; Type 0: Not a Combination Product	10/06/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	10/06/2023

Labeler - IIMED MEDICAL MEXICANA S DE RL DE CV (812894376)

Registrant - Team Technologies (192339703)

Establishment
Name	Address	ID/FEI	Business Operations
IIMED MEDICAL MEXICANA S DE RL DE CV		812894376	relabel(83062-030) , repack(83062-030)