COLGATE TOTAL GUM PROTECTION- stannous fluoride paste, dentifrice 
Colgate-Palmolive

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Colgate® Total Gum Protection

Drug Facts

Active ingredient

Stannous Fluoride 0.454% (0.15% w/v fluoride ion)

Purposes

Anticavity, Antigingivitis, Antisensitivity

Uses

Warnings

When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist.

Stop use and ask a dentist if the sensitivity problem persists or worsens.

Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a dentist if

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease.

Directions

Other information

Inactive ingredients

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-12, Tetrasodium Pyrophosphate, Sodium Lauryl Sulfate, Flavor, Zinc Phosphate, Cellulose Gum, Sodium Citrate, Microcrystalline Cellulose, Sodium Saccharin, Cocamidopropyl Betaine, Xanthan Gum, Citric Acid, Sucralose, Titanium Dioxide.

Questions?

1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE CO.
New York, NY 10022 U.S.A.

PRINCIPAL DISPLAY PANEL - Two 136 g Tube Carton

Colgate®
Anticavity, Antigingivitis and Antisensitivity Toothpaste

Recyclable
Tube

✓CAVITIES ✓PLAQUE ✓GINGIVITIS ✓ENAMEL ✓TARTAR ✓FRESH BREATH
✓WHITENS ✓SENSITIVITY RELIEF ✓DEEP CLEAN ✓ODOR NEUTRALIZATION

FIGHTS BACTERIA ON TEETH, TONGUE, CHEEKS AND GUMS

2
VALUE
PACK

Total
WHOLE MOUTH HEALTH

12
HR
ANTIBACTERIAL
PROTECTION*

STANNOUS FLUORIDE

GUM
PROTECTION
Paste

TWO 4.8 OZ (136 g) TUBES
TOTAL NET WT 9.6 OZ (272 g)

PRINCIPAL DISPLAY PANEL - Two 136 g Tube Carton
COLGATE TOTAL GUM PROTECTION 
stannous fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-572
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
ZINC PHOSPHATE (UNII: 1E2MCT2M62)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-572-481 in 1 CARTON12/11/2020
1136 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-572-962 in 1 CARTON12/21/2020
2136 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:35000-572-321 in 1 CARTON01/21/2021
393 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/11/2020
Labeler - Colgate-Palmolive (001344381)
Establishment
NameAddressID/FEIBusiness Operations
Colgate-Palmolive Company785047999ANALYSIS(35000-572) , LABEL(35000-572) , MANUFACTURE(35000-572) , PACK(35000-572)

Revised: 11/2021
Document Id: aa8e22ab-777e-4785-bc29-9d577bce7cce
Set id: 21d08a51-3672-028f-77a0-a24775279c89
Version: 4
Effective Time: 20211105
 
Colgate-Palmolive