COLGATE KIDS BUBBLEGUM SWIRL- 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 Bubblegum Swirl

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:

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision

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

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

Other Information

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

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®

Kids

Anticavity
Fluoride Rinse

Bubble Gum
Swirl

P9896332

8.4 FL OZ
(250 mL)

Protects
from
Cavities

Strengthens
Enamel

Cleans
the Whole
Mouth*

IMPORTANT: Read directions for proper use

Principal Display Panel - 250 mL Bottle Label
COLGATE KIDS BUBBLEGUM SWIRL 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-725
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)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLOXAMER 338 (UNII: F75JV2T505)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-725-84250 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:35000-725-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:35000-725-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35508/01/2014
Labeler - Colgate-Palmolive Company (068693167)

Revised: 12/2015
Document Id: 253b6909-1cda-4d2f-9a1b-d42078b97a36
Set id: f4e7163c-625d-4547-b4aa-83dba0c2644c
Version: 2
Effective Time: 20151201
 
Colgate-Palmolive Company