COLGATE  FLUORIDE WHITENING - REVIVING MINT- sodium fluoride gel, 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 Reviving Mint Gel

Drug Facts

Active ingredient

Sodium fluoride 0.24 (0.15% 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, cocamidopropyl betaine, sodium hydroxide, sodium saccharin, xanthan gum, FD&C blue no. 1

Questions or comments?

Call toll-free 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 113 g Carton

Gel

Colgate®
Anticavity Fluoride Whitening Toothpaste

PRO
CLINICAL™
white

WHITER TEETH IN JUST 1 TUBE

NET WT 4.0 OZ (113 g)

Clinically Proven WHITENING TECHNOLOGY.

Principal Display Panel - 113 g Carton
COLGATE   FLUORIDE WHITENING - REVIVING MINT
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51442-546
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, UNSPECIFIED FORM (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)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51442-546-691 in 1 CARTON11/10/201006/01/2019
1113 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: 7a890f9b-cae0-48a9-9676-527fe41a1f7c
Set id: 7b38287b-6376-4712-8b95-ba31863f4328
Version: 3
Effective Time: 20190906
 
Colgate-Palmolive Canada