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Drug Facts
Distributed by: LEC Custom Products, Inc. Mississauga, ON. L5S 1B8
Made in Canada
Percara Oral Health Rinse
FDA Label NDC 67933-0321
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lec Custom Products, Inc for the product Percara Oral Health Rinse (NDC 67933-0321). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient
Cetylpyridinium chloride 0.07%
Otc - Purpose
Purpose
Antigingivitis
Antiplaque
Indications & Usage
Use helps control plaque that leads to gingivitis.
Warnings
Warning
Otc - Stop Use
Stop use and ask a dentist 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 increased spacing between the teeth. These may be symptoms of periodontitis, a serious form of gum disease.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help.
Dosage & Administration
Directions
- adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
- do not swallow
- children 6 to Under 12 years of age: supervise use
- when used after brushing. rinse mouth with water first
- children under 6 years of age: do not use
Other Safety Information
Other Information
this rinse is not intended to replace brushing or flossing
Inactive Ingredient
Inactive Ingredients water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1
Package Label.Principal Display Panel
PERCARA™
FRESH MINT
ORAL HEALTH RINSE
ALCOHOL FREE
KILLS GERMS
FRESHENS BREATH
PREVENTS GINGIVITIS
16.9 FL OZ (500mL)
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