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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COLGATE® 2IN1 TOOTHPASTE AND MOUTHWASH ICY BLAST® LIQUID GEL

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 olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

water, sorbitol, hydrated silica, glycerin, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, sodium saccharin, cocamidopropyl betaine, cellulose gum, xanthan gum, mica, titanium dioxide, D&C red no. 33 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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65954-355
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL331.2 mg  in 1 g
WATER 
GLYCERIN 
HYDRATED SILICA 
SODIUM LAURYL SULFATE 
COCAMIDOPROPYL BETAINE 
SODIUM PYROPHOSPHATE 
SACCHARIN SODIUM 
MICA 
TITANIUM DIOXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
XANTHAN GUM 
D&C RED NO. 33 
FD&C BLUE NO. 1 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-355-81130 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35507/26/2011
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 7/2013
Document Id: 3c8cb9db-9dc1-489e-b83b-e0750b5092f3
Set id: 23aa663d-338a-49b3-89fe-d79d3299c8b6
Version: 2
Effective Time: 20130715
 
Mission Hills S.A de C.V