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 older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years ask 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 Type HUMAN OTC DRUG Item Code (Source) NDC:65954-536
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.1 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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 (UNII: K679OBS311)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color BLUE, WHITE, GREEN Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65954-536-79 1 in 1 CARTON
1 79 g in 1 TUBE
2 NDC:65954-536-63 1 in 1 CARTON
2 85 g in 1 TUBE
3 NDC:65954-536-69 1 in 1 CARTON
3 113 g in 1 TUBE
4 NDC:65954-536-46 1 in 1 CARTON
4 130 g in 1 TUBE
5 NDC:65954-536-64 1 in 1 CARTON
5 181 g in 1 TUBE
6 NDC:65954-536-82 1 in 1 CARTON
6 232 g in 1 TUBE
7 NDC:65954-536-60 1 in 1 CARTON
7 170 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 12/01/2010
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