DUOCARE CLINICAL ORAL RINSE- cetylpyridinium chloride mouthwash mouthwash 
IIMED MEDICAL MEXICANA S DE RL DE CV

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IIMED DUOCARE CLINICAL ORAL RINSE

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

Entire Label

DUOCARE CLINICAL ORAL RINSE 
cetylpyridinium chloride mouthwash mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83062-030(NDC:53329-030)
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83062-030-1359 mL in 1 BOTTLE; Type 0: Not a Combination Product10/06/2023
2NDC:83062-030-077 mL in 1 POUCH; Type 0: Not a Combination Product10/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02210/06/2023
Labeler - IIMED MEDICAL MEXICANA S DE RL DE CV (812894376)
Registrant - Team Technologies (192339703)
Establishment
NameAddressID/FEIBusiness Operations
IIMED MEDICAL MEXICANA S DE RL DE CV812894376relabel(83062-030) , repack(83062-030)

Revised: 10/2023
Document Id: 08272b36-9e91-1228-e063-6294a90a90eb
Set id: 07120987-97f3-9b6a-e063-6394a90a6a76
Version: 2
Effective Time: 20231020
 
IIMED MEDICAL MEXICANA S DE RL DE CV