COLGATE 2IN1 ICY BLAST- 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% (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of cavities

Warnings

Keep out of the 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

water, sorbitol, hydrated silica, glycerin, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, polyethylene, sodium, saccharin, cocamidopropyl betaine, cellulose gum, xanthan gum, mica, titanium dioxide, FD&C blue no. 1

Questions?

Call toll-free 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 130 g Bottle Label

2 in 1
Toothpaste
& Mouthwash

Colgate®
Fluoride Toothpaste

Cleans Teeth & Freshens Breath

Icy Blast ®
Whitening

NET WT 4.6 OZ (130 g)
LIQUID GEL

PRINCIPAL DISPLAY PANEL - 130 g Bottle Label

COLGATE 2IN1 ICY BLAST
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-355
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	331.2 mg in 1 g
WATER
GLYCERIN
HYDRATED SILICA
HIGH DENSITY POLYETHYLENE
SODIUM LAURYL SULFATE
COCAMIDOPROPYL BETAINE
SODIUM PYROPHOSPHATE
SACCHARIN SODIUM
MICA
TITANIUM DIOXIDE
CARBOXYMETHYLCELLULOSE SODIUM
XANTHAN GUM
FD&C BLUE NO. 1

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

Packaging
#	Item Code	Package Description
1	NDC:65954-355-81	130 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	07/26/2011

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

Revised: 05/2013

Document Id: a36ef90e-9c66-41eb-9dc6-216cb34927be

Set id: 23aa663d-338a-49b3-89fe-d79d3299c8b6

Version: 1

Effective Time: 20130530

Mission Hills S.A de C.V