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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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 (FLUORIDE ION)	FLUORIDE ION	1.1 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDRATED SILICA	220 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
Color	BLUE, WHITE, GREEN	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description
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

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: 01/2013

Document Id: 072ab7a8-feb1-4f5e-afb1-d4d4cce9cc2a

Set id: 85b37d72-a3d0-40ef-a7a2-49f3b2e3cdb4

Version: 5

Effective Time: 20130130

Mission Hills S.A de C.V