COLGATE MAXFRESH FRESH MINT- sodium fluoride gel, 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® Max Fresh® One Direction 4.6 oz Fluoride Toothpaste

Drug Facts

Active Ingredient

Sodium fluoride 0.24% (0.14% 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, PEG-12, sodium lauryl sulfate, tetrasodium pyrophosphate, flavor, cocamidopropyl betaine, sodium saccharin, cellulose gum, xanthan gum, mica, titanium dioxide, FD&C blue no. 1

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 130 g Bottle Label

1D™

Colgate®

Fluoride Toothpaste

1D™

Fresh Mint

NET WT 4.6 OZ (130g) LIQUID GEL

Principal Display Panel - 130 g Bottle Label

COLGATE MAXFRESH FRESH MINT
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:65954-010
Route of Administration	DENTAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
SORBITOL	670 mg in 1 g
WATER
HYDRATED SILICA
POLYETHYLENE GLYCOL 600
SODIUM LAURYL SULFATE
SODIUM PYROPHOSPHATE
COCAMIDOPROPYL BETAINE
SACCHARIN SODIUM
CARBOXYMETHYLCELLULOSE SODIUM
XANTHAN GUM
MICA
TITANIUM DIOXIDE
FD&C BLUE NO. 1

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65954-010-81	130 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part355	01/08/2013

Labeler - Mission Hills S.A de C.V (812312122)

Revised: 1/2013

Document Id: 081e0c58-71cb-4c2d-a049-f0b8237df88f

Set id: 347c8c99-46e0-4def-8b95-538ea293e1c5

Version: 1

Effective Time: 20130110

Mission Hills S.A de C.V