Colgate® Tartar Protection Whitening Fluoride Toothpaste Cool Mint

Drug Labeling and Warnings

Drug Details [pdf]

COLGATE  TARTAR PROTECTION WHITENING FLUORIDE COOL MINT- sodium fluoride paste, dentifrice 
Colgate-Palmolive

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® Tartar Protection Whitening Fluoride Toothpaste Cool Mint

Drug Facts

Active ingredient

Sodium fluoride 0.24% (0.16% 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

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

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 181 g Tube Carton

Colgate®
Fluoride Toothpaste

NET WT 6.4 OZ (181 g)

Tartar
Protection
Whitening

Fights Tartar and
Whitens Teeth

Cool Mint
Gel

PRINCIPAL DISPLAY PANEL - 181 g Tube Carton
COLGATE   TARTAR PROTECTION WHITENING FLUORIDE COOL MINT
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 35000-163
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
Sorbitol (UNII: 506T60A25R)  
Water (UNII: 059QF0KO0R)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Glycerin (UNII: PDC6A3C0OX)  
Polyethylene Glycol 600 (UNII: NL4J9F21N9)  
SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM (UNII: 5HK03SA80J)  
Sodium Pyrophosphate (UNII: O352864B8Z)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
Carrageenan (UNII: 5C69YCD2YJ)  
Mica (UNII: V8A1AW0880)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
FD&C Blue no. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 35000-163-641 in 1 CARTON08/29/201208/01/2019
1181 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35508/29/201208/01/2019
Labeler - Colgate-Palmolive (068693167)

Revised: 9/2019
Document Id: 76a8d305-cf9f-4f76-b829-21221882e1a6
Set id: 1e5c4736-de84-416f-9b1d-bcc59a373e14
Version: 2
Effective Time: 20190906
 
Colgate-Palmolive