Colgate® Triple Action Fluoride Toothpaste

Colgate Triple Action by

Drug Labeling and Warnings

Colgate Triple Action by is a Otc medication manufactured, distributed, or labeled by Mission Hills S.A de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 DRUGItem Code (Source)NDC: 65954-536
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA (UNII: Y6O7T4G8P9) 220 mg  in 1 g
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE, WHITE, GREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65954-536-791 in 1 CARTON12/01/2010
179 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 65954-536-631 in 1 CARTON12/01/2010
285 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 65954-536-691 in 1 CARTON12/01/2010
3113 g in 1 TUBE; Type 0: Not a Combination Product
4NDC: 65954-536-461 in 1 CARTON12/01/2010
4130 g in 1 TUBE; Type 0: Not a Combination Product
5NDC: 65954-536-641 in 1 CARTON12/01/2010
5181 g in 1 TUBE; Type 0: Not a Combination Product
6NDC: 65954-536-821 in 1 CARTON12/01/2010
6232 g in 1 TUBE; Type 0: Not a Combination Product
7NDC: 65954-536-601 in 1 CARTON12/01/2010
7170 g in 1 TUBE; Type 0: Not a Combination Product
8NDC: 65954-536-481 in 1 CARTON12/01/2010
8226 g in 1 TUBE; Type 0: Not a Combination Product
9NDC: 65954-536-581 in 1 CARTON12/01/2010
970 g in 1 TUBE; Type 0: Not a Combination Product
10NDC: 65954-536-921 in 1 CARTON12/01/2010
10141 g in 1 TUBE; Type 0: Not a Combination Product
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: 4/2019
Document Id: a834022b-a11c-4531-9478-07f659a306da
Set id: 85b37d72-a3d0-40ef-a7a2-49f3b2e3cdb4
Version: 9
Effective Time: 20190411
 
Mission Hills S.A de C.V