Colgate® Anticavity Fluoride and Antigingivitis Toothpaste

Drug Labeling and Warnings

Drug Details [pdf]

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

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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:

  • 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 olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician
children under 12 yearsinstruct in good brushing and rinsing habits
(to minimize swallowing)
children under 6 yearsdo 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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 65954-353
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65954-353-661 in 1 CARTON07/07/200908/01/2019
1164 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02023107/07/200908/01/2019
Labeler - Colgate-Palmolive Company (812312122)

Revised: 9/2019
Document Id: a007dddc-1eb0-49b1-bfb6-ce84421051b0
Set id: 777dbfc2-8cc2-419e-afa8-d4650c0475a2
Version: 2
Effective Time: 20190912