Colgate Total Whitening Gel

Generic Name: sodium fluoride and triclosan
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:

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  • 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 Item Code (Source) NDC: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
Product Characteristics
Color WHITE, BLUE Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:65954-002-78 1 TUBE (TUBE) in 1 CARTON
1 221 g in 1 TUBE
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: 09/2010
 
Mission Hills, S.A. de C.V.



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