COLGATE PROCLINICAL - SPARKLING MINT- sodium fluoride paste, dentifrice 
Colgate-Palmolive Canada

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®
PRO
CLINICAL™
white

Drug Facts

Active ingredient

Sodium fluoride 0.24% (1.5% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

water, hydrated silica, sorbitol, glycerin, PEG-12, pentasodium triphosphate, tetrasodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, polyethylene, cocamidopropyl betaine, sodium hydroxide, sodium saccharin, xanthan gum, titanium dioxide, FD&C blue no. 1 lake

Questions or comments?

Call toll-free 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 164 g tube carton

Paste

Colgate®
Anticavity Fluoride Whitening Toothpaste

PRO
CLINICAL™
white

WHITER TEETH IN JUST 1 TUBE

NET WT 5.8 OZ (164 g)

Clinically Proven WHITENING TECHNOLOGY.

PRINCIPAL DISPLAY PANEL - 164 g tube carton
COLGATE PROCLINICAL - SPARKLING MINT 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51442-543
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
hydrated silica (UNII: Y6O7T4G8P9)  
sorbitol (UNII: 506T60A25R)  
glycerin (UNII: PDC6A3C0OX)  
Polyethylene Glycol 600 (UNII: NL4J9F21N9)  
sodium tripolyphosphate (UNII: 5HK03SA80J)  
sodium pyrophosphate (UNII: O352864B8Z)  
sodium lauryl sulfate (UNII: 368GB5141J)  
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)  
cocamidopropyl betaine (UNII: 5OCF3O11KX)  
sodium hydroxide (UNII: 55X04QC32I)  
saccharin sodium (UNII: SB8ZUX40TY)  
xanthan gum (UNII: TTV12P4NEE)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorWHITE (Blue Speckles) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51442-543-661 in 1 CARTON11/10/201006/01/2019
1164 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/10/201006/01/2019
Labeler - Colgate-Palmolive Canada (259157246)

Revised: 9/2019
Document Id: e6653cd9-21d6-4057-be1b-6f5631d8d8e7
Set id: fb49c2dd-b735-44bf-a302-019a0fe81603
Version: 2
Effective Time: 20190910
 
Colgate-Palmolive Canada