COLGATE MAXFRESH COOLSCRUB MINTBLAST WITH WHITENING- 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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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, PEG-12, flavor, sodium lauryl sulfate, cellulose gum, sodium saccharin, tetrasodium pyrophosphate, cocamidopropyl betaine, lactose monohydrate, 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 - 170 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

Destroys Bad Breath Bacteria from Teeth & Tongue.* All Out Freshness!

NEW

with Microscrubbers
MaxFresh®
COOL SCRUB™

MintBlast WITH WHITENING

NET WT 6.0 OZ (170 g)

Principal Display Panel - 170 g Tube Carton

COLGATE MAXFRESH COOLSCRUB MINTBLAST WITH WHITENING
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-062
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
SORBITOL	562.88 mg in 1 g
WATER
HYDRATED SILICA
POLYETHYLENE GLYCOL 600
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM
SACCHARIN SODIUM
SODIUM PYROPHOSPHATE
COCAMIDOPROPYL BETAINE
LACTOSE MONOHYDRATE
MICA
TITANIUM DIOXIDE
FD&C BLUE NO. 1

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

Packaging
#	Item Code	Package Description
1	NDC:65954-062-60	1 in 1 CARTON
1		170 g in 1 TUBE
2	NDC:65954-062-79	1 in 1 CARTON
2		79 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	05/22/2013

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

Revised: 04/2013

Document Id: 77a1d2f2-530e-40d5-97c9-8e6f2ce0cca5

Set id: cbad1402-25f7-4599-9c37-0d46bdec3f23

Version: 1

Effective Time: 20130419

Mission Hills S.A de C.V