COLGATE TRIPLE ACTION- sodium fluoride paste, dentifrice 
Mission Hills S.A de C.V

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® Triple Action Fluoride Toothpaste

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

sorbitol, water, hydrated silica, sodium lauryl sulfate, flavor, PEG-12, tetrasodium pyrophosphate, cocamidopropyl betaine, cellulose gum, sodium saccharin, xanthan gum, titanium dioxide, FD&C blue no. 1, FD&C yellow no. 5

Questions?

1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE
COMPANY
New York 10022

PRINCIPAL DISPLAY PANEL - 232 g Tube Carton

Three Benefits for a Deep Clean

Colgate®
Fluoride Toothpaste

NET WT 8.2 OZ (232 g)

Triple
Action

Original Mint

Cavity
Protection
1

Whiter
Teeth
2

Fresh
Breath
3

PRINCIPAL DISPLAY PANEL - 232 g Tube Carton
COLGATE TRIPLE ACTION 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65954-536
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA220 mg  in 1 g
WATER 
SORBITOL 
POLYETHYLENE GLYCOL 600 
FD&C BLUE NO. 1 
SODIUM LAURYL SULFATE 
COCAMIDOPROPYL BETAINE 
SODIUM PYROPHOSPHATE 
CARBOXYMETHYLCELLULOSE SODIUM 
FD&C YELLOW NO. 5 
SACCHARIN SODIUM 
XANTHAN GUM 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUE, WHITE, GREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-536-791 in 1 CARTON
179 g in 1 TUBE
2NDC:65954-536-631 in 1 CARTON
285 g in 1 TUBE
3NDC:65954-536-691 in 1 CARTON
3113 g in 1 TUBE
4NDC:65954-536-461 in 1 CARTON
4130 g in 1 TUBE
5NDC:65954-536-641 in 1 CARTON
5181 g in 1 TUBE
6NDC:65954-536-821 in 1 CARTON
6232 g in 1 TUBE
7NDC:65954-536-601 in 1 CARTON
7170 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/01/2010
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 7/2013
Document Id: b4e581f5-03b5-4a46-8132-4325f424e731
Set id: 85b37d72-a3d0-40ef-a7a2-49f3b2e3cdb4
Version: 6
Effective Time: 20130724
 
Mission Hills S.A de C.V