COLGATE  TOTAL GUM DEFENSE- silicon dioxide, sodium fluoride, and triclosan paste, dentifrice 
Colgate-Palmolive

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Colgate®
Total®
GUM
DEFENSE

Drug Facts

Active ingredientsPurpose
Sodium fluoride 0.24% (0.15% 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 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, sodium saccharin, carrageenan, titanium dioxide

Question or comments?

Call toll-free 1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

NEW

Colgate®
Anticavity Fluoride and Antigingivitis Toothpaste

ADA
Accepted
American
Dental
Association ®
Helps Prevent: Cavities • Gingivitis • Plaque   Fights Tartar • Freshens Breath • Whitens

NET WT 4.0 OZ (113 g)

Paste

Total®

GUM
DEFENSE

HELPS PREVENT &
REDUCE GINGIVITIS

Principal Display Panel - 113 g Tube Carton
COLGATE   TOTAL GUM DEFENSE
silicon dioxide, sodium fluoride, and triclosan paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-048
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide50 mg  in 1 g
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion2.4 mg  in 1 g
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Hydrated Silica (UNII: Y6O7T4G8P9)  
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Sorbitol (UNII: 506T60A25R)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Carrageenan (UNII: 5C69YCD2YJ)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-048-161 in 1 CARTON06/25/201110/30/2012
121.2 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-048-691 in 1 CARTON06/25/201110/22/2013
2113 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:35000-048-471 in 1 CARTON06/25/201108/01/2011
3147 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:35000-048-541 in 1 CARTON06/25/201112/10/2013
4198 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02023106/25/201112/10/2013
Labeler - Colgate-Palmolive (068693167)

Revised: 1/2018
Document Id: 7e9b10f0-e0b6-4711-aed2-a91c33dd4793
Set id: 0c19f549-b64b-487e-b582-e31a3d6bef3c
Version: 2
Effective Time: 20180118
 
Colgate-Palmolive