Colgate Total Whitening Gel

Dosage Form: gel, dentifrice
Colgate®

Total®

Whitening Gel

Drug Facts

Active ingredients	Purpose
Sodium fluoride 0.24% (0.14% w/v fluoride ion)	Anticavity
Triclosan 0.30%	Antigingivitis

Uses

aids in the prevention of:

• cavities


• plaque


• gingivitis

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.

Ask a dentist before use if you have

• bleeding or redness lasting more than 2 weeks


• pain, swelling, pus, loose teeth, or more spacing between teeth

These may be signs of periodontitis, a serious form of gum disease.

Directions

supervise children as necessary until capable of using without supervision.

adults and children 6 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 a physician
children under 12 years	instruct in good brushing and rinsing habits (to minimize swallowing)
children under 6 years	do not use unless directed by a dentist or a physician

Antiplaque and antigingivitis use not proven in children.

Inactive ingredients

water, hydrated silica, glycerin, sorbitol, PVM/MA copolymer, sodium lauryl sulfate, cellulose gum, flavor, sodium hydroxide, propylene glycol, carrageenan, sodium saccharin, mica, titanium dioxide, FD&C blue no.1

Questions or comments?

Call toll-free 1-800-468-6502

Dist. by:

COLGATE-PALMOLIVE COMPANY

New York, NY 10022

www.colgatetotal.com

PRINCIPAL DISPLAY PANEL - 221 g Tube Carton

Helps Prevent Cavities • Gingivitis • Plaque

Colgate®

Anticavity Fluoride and Antigingivitis Toothpaste

Total®

Whitening

Gel

ADA

Accepted

American

Dental

Association ®

NET WT 7.8 OZ (221 g)

Fights Tartar Buildup • Whitens Teeth

COLGATE  TOTAL WHITENING sodium fluoride and triclosan  gel, dentifrice

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 65954-002 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (Fluoride Ion) Sodium Fluoride 2.4 mg  in 1 g Triclosan (Triclosan) Triclosan 3 mg  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE, BLUE Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65954-002-78 1 TUBE In 1 CARTON contains a TUBE 1 221 g In 1 TUBE This package is contained within the CARTON (65954-002-78)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020231	10/01/2009

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

Revised: 09/2010Mission Hills, S.A. de C.V.

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