PERCARA ORAL HEALTH RINSE FRESH MINT- cetylpyridinium chloride rinse

PerCara Oral Health Rinse by

Drug Labeling and Warnings

PerCara Oral Health Rinse by is a Otc medication manufactured, distributed, or labeled by LEC Custom Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient
Cetylpyridinium chloride 0.07%

PURPOSE

Purpose

Antigingivitis

Antiplaque

INDICATIONS & USAGE

Use helps control plaque that leads to gingivitis.

WARNINGS

Warning

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.

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

SPL UNCLASSIFIED SECTION

Distributed by: LEC Custom Products, Inc. Mississauga, ON. L5S 1B8

Made in Canada

PRINCIPAL DISPLAY PANEL

PERCARA™

FRESH MINT

ORAL HEALTH RINSE

ALCOHOL FREE

KILLS GERMS

FRESHENS BREATH

PREVENTS GINGIVITIS

16.9 FL OZ (500mL)

INGREDIENTS AND APPEARANCE

PERCARA ORAL HEALTH RINSE  FRESH MINT
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67933-0321
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.07 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POLOXAMER 188 (UNII: LQA7B6G8JG)
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67933-0321-1	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	03/15/2021

Labeler - LEC Custom Products, Inc (204065726)

Establishment
Name	Address	ID/FEI	Business Operations
LEC Custom Products, Inc		204064757	manufacture(67933-0321)