PERCARA KIDS BUBBLE GUM- sodium fluoride rinse 
LEC Custom Products, Inc.

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PerCara Bubblegum Fluoride Rinse

Drug Facts

Active Ingredients

Sodium fluoride 0.05% (Fluoride ion-0.0226%)

Purpose

Anticavity rinse

Uses

aids the prevention of dental cavities

Warning

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Inactive ingredients benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene plycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Other information

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

MADE IN CANADA

PERCARA™

ALCOHOL FREE

CAVITY PROTECTION

kids BUBBLE GUM

FLUORIDE RINSE

18 FL OZ (532 ML)PERCARA - Kids BG Fluoride Rinse

PERCARA KIDS BUBBLE GUM 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67933-0016
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67933-0016-1532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/23/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02103/23/2021
Labeler - LEC Custom Products, Inc. (204065726)
Establishment
NameAddressID/FEIBusiness Operations
LEC Custom Products, Inc204064757manufacture(67933-0016)

Revised: 1/2024
Document Id: 0eb3968a-ead0-c8c9-e063-6394a90a06e5
Set id: be3a7272-acfb-7d14-e053-2995a90a9420
Version: 2
Effective Time: 20240101
 
LEC Custom Products, Inc.