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

----------

Colgate®
Triple
Action
Original Mint

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 or comments?

Call 1-800-468-6502

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

Made in Mexico

www.colgate.com

PRINCIPAL DISPLAY PANEL - 181 g Carton

Colgate®
Fluoride Toothpaste

NET WT 6.4 OZ (181 g)

Triple
Action

Original Mint

Cavity
Protection
1

Whiter
Teeth
2

Fresh
Breath
3

COLGATE TRIPLE ACTION  sodium fluoride   paste, dentifrice

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 65954-536 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (fluoride ion) SODIUM FLUORIDE 2.4 mg  in 1 g

Inactive Ingredients Ingredient Name Strength WATER 88.58 mg  in 1 g HYDRATED SILICA 220 mg  in 1 g SORBITOL 590 mg  in 1 g POLYETHYLENE GLYCOL 600 10 mg  in 1 g FD&C BLUE NO. 1 0.05 mg  in 1 g SODIUM LAURYL SULFATE 51.72 mg  in 1 g COCAMIDOPROPYL BETAINE 12.5 mg  in 1 g SODIUM PYROPHOSPHATE 5 mg  in 1 g CARBOXYMETHYLCELLULOSE SODIUM 3 mg  in 1 g FD&C YELLOW NO. 5 0.018 mg  in 1 g SACCHARIN SODIUM 2.7 mg  in 1 g XANTHAN GUM 2 mg  in 1 g TITANIUM DIOXIDE 10 mg  in 1 g

Product Characteristics Color BLUE, WHITE, GREEN Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65954-536-64 1 TUBE In 1 CARTON contains a TUBE 1 181 g In 1 TUBE This package is contained within the CARTON (65954-536-64)

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)

Establishment
Name	Address	ID/FEI	Operations
Mission Hills S.A. de C.V.		812312122	MANUFACTURE

Revised: 12/2010Mission Hills S.A. de C.V.