DuoCare™ Clinical Oral Rinse

DuoCare™ Clinical Oral Rinse

Drug Labeling and Warnings

Drug Details

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DUOCARE CLINICAL ORAL RINSE- cetylpyridinium chloride mouthwash 
Medline Industries, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 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: do not use.

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

Label

DUOCARE CLINICAL ORAL RINSE 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-030-1359 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
2NDC: 53329-030-077 mL in 1 POUCH; Type 0: Not a Combination Product11/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/01/2018
Labeler - Medline Industries, Inc. (025460908)
Establishment
NameAddressID/FEIBusiness Operations
Unette Corporation011401882pack(53329-030)
Establishment
NameAddressID/FEIBusiness Operations
Applied Laboratories, Inc.117337220manufacture(53329-030)

Revised: 2/2020
 
Medline Industries, Inc.


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