COLGATE TOTAL ADVANCED CLEAN- sodium fluoride and triclosan paste, dentifrice 
Colgate-Palmolive Company

----------

Colgate®
Anticavity Fluoride
and Antigingivitis Toothpaste

Drug Facts

Active ingredients

Sodium fluoride 0.24% (0.14% w/v fluoride ion)

Triclosan 0.30%

Purpose

Anticavity

Antigingivitis

Uses

aids in the prevention of:

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

hydrated silica, water, glycerin, sorbitol, PVM/MA copolymer, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, propylene glycol, carrageenan, sodium saccharin, titanium dioxide

Questions or comments?

Call toll-free 1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022
Made in Mexico
www.colgate.com

PRINCIPAL DISPLAY PANEL - 5.8 OZ Tube

Helps Prevent Cavities • Gingivitis • Plaque

Colgate®
Anticavity Fluoride and Antigingivitis Toothpaste

Total®

ADVANCED CLEAN
PLUS
WHITENING

PASTE

EXTRA
CLEAN &
HEALTHY
MOUTH

ADA
ACCEPTED

American
Dental
Association ®

NET WT 5.8 OZ (164 g)

Principle Display Panel - 5.8 OZ Tube

PRINCIPAL DISPLAY PANEL - 5.8 OZ carton

Helps Prevent Cavities • Gingivitis • Plaque

Colgate®
Anticavity Fluoride and Antigingivitis Toothpaste

Total®

ADVANCED CLEAN
PLUS
WHITENING

PASTE

EXTRA
CLEAN &
HEALTHY
MOUTH

ADA
ACCEPTED

American
Dental
Association ®

NET WT 5.8 OZ (164 g)

Principle Display Panel - 5.8 OZ carton
COLGATE  TOTAL ADVANCED CLEAN
sodium fluoride and triclosan paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65954-353
Route of Administration DENTAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.4 mg  in 1 g
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 3 mg  in 1 g
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65954-353-66 1 in 1 CARTON
1 164 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020231 07/07/2009
Labeler - Colgate-Palmolive Company (812312122)

Revised: 7/2009
Document Id: 34312b6f-36d6-4352-8222-975b6a72b333
Set id: 777dbfc2-8cc2-419e-afa8-d4650c0475a2
Version: 1
Effective Time: 20090713
 
Colgate-Palmolive Company