COLGATE KIDS TROLLS ALCOHOL FREE ANTI-CAVITY SPARKLE TIME BUBBLE FRUIT- sodium fluoride rinse 
Colgate-Palmolive Company

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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Colgate® Kids Trolls Alcohol Free Anti-Cavity Sparkle Time™ Bubble Fruit®

Drug Facts

Active ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

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 6 years of age and older:

Children under 6 years of age: consult a dentist or doctor

Other information

Store at controlled room temperature 68 – 77° F (20 – 25°C)

Inactive ingredients

water, glycerin, propylene glycol, sorbitol, poloxamer 338, poloxamer 407, flavor, PEG-40 castor oil, phosphoric acid, sodium saccharin, disodium phosphate, potassium sorbate, cetylpyridinium chloride, sucralose, D&C red no. 33, FD&C green no. 3

Questions?

1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE
COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 250 mL Bottle Label

NEW

ALCOHOL FREE
Colgate®

Anticavity Fluoride Rinse

Kids

DREAMWORKS
Trolls

Strengthens
Enamel
Protects from
Cavities
Cleans the
Whole Mouth*

P9913559

8.4 FL OZ
(250mL)

Sparkle Time™ Bubble Fruit®
IMPORTANT: Read directions for proper use

PRINCIPAL DISPLAY PANEL - 250 mL Bottle Label
COLGATE KIDS TROLLS ALCOHOL FREE ANTI-CAVITY SPARKLE TIME BUBBLE FRUIT 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-383
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 338 (UNII: F75JV2T505)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-383-84250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/28/201912/30/2024
2NDC:35000-383-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/04/201612/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35508/05/201612/30/2024
Labeler - Colgate-Palmolive Company (001344381)

Revised: 1/2023
Document Id: c0df753b-f0f6-4f7e-865e-4ec486226999
Set id: 892ed52c-b502-43c2-84ae-7c4bd2d72b5c
Version: 5
Effective Time: 20230125
 
Colgate-Palmolive Company