Active Ingredient
Cetylpyridinium Chloride 0.1%
Duocare Clinical Oral Rinse Mouthwash
FDA Label NDC 53329-030
12 label sections · Submitted to the FDA by Medline Industries, Lp · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Duocare Clinical Oral Rinse (NDC 53329-030). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigingivitis/Antiplaque
Uses
- helps prevent and reduce plaque that leads to gingivitis and bleeding gums
Warnings
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 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
www.medline.com
DuoCare is a trademark of Medline Industries, LP.
Manufactured for:
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
1-800-MEDLINE (633-5463)
REF: MDS096316
Recent Major Changes
- Dosage and Administration
Package Label
Bottle Label (53329 030 Bottle V1)
* Please review the disclaimer below.
