COLGATE TOTAL SF ADVANCED WHITENING- stannous fluoride paste, dentifrice 
Colgate-Palmolive Company

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® TotalSF Advanced Whitening Paste

Drug Facts

Active ingredient

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

Purposes

Anticavity, Antigingivitis, Antisensitivity

Uses

  • aids in the prevention of cavities
  • helps prevent gingivitis
  • helps interfere with harmful effects of plaque associated with gingivitis
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

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
  • if 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

  • adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist.
    Make sure to brush all sensitive areas of the teeth.
  • do not swallow.
  • children under 12 years of age: consult a dentist.

Other information

  • products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • this Colgate product is specially formulated to help prevent staining.

Inactive ingredients

glycerin, hydrated silica, water, propylene glycol, PEG-12, pentasodium triphosphate, sodium citrate, sodium lauryl sulfate, flavor, PVP, microcrystalline cellulose, trisodium phosphate, zinc oxide, citric acid, zinc citrate, phosphoric acid, sodium saccharin, cocamidopropyl betaine, carrageenan, xanthan gum, PVM/MA copolymer, sucralose, titanium dioxide

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 2 Tube Carton

Colgate®
Anticavity, Antigingivitis and Antisensitivity Toothpaste

✓CAVITIES ✓PLAQUE ✓GINGIVITIS ✓ENAMEL ✓TARTAR ✓BREATH ✓WHITENS
now with SENSITIVITY RELIEF

PROTECTS TEETH, TONGUE, CHEEKS & GUMS

SEE NEW INFORMATION AND DIRECTIONS

TWO 5.1 OZ (144 g) TUBES
TOTAL NET WT 10.2 OZ (288 g)

VALUE 2 PACK

NEW ACTIVE INGREDIENT
STANNOUS FLUORIDE

TotalSF
WHOLE MOUTH HEALTH

ADVANCED
WHITENING

Paste

PRINCIPAL DISPLAY PANEL - 2 Tube Carton
COLGATE TOTAL SF ADVANCED WHITENING 
stannous fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-171
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)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
ZINC PHOSPHATE (UNII: 1E2MCT2M62)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-171-251 in 1 CARTON11/01/201801/01/2022
124.9 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-171-931 in 1 CARTON11/01/201801/01/2022
296 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:35000-171-471 in 1 CARTON11/01/201801/01/2022
3144 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:35000-171-652 in 1 CARTON11/01/201801/01/2022
4144 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:35000-171-641 in 1 CARTON11/01/201801/01/2022
5181 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/01/201801/08/2022
Labeler - Colgate-Palmolive Company (001344381)
Establishment
NameAddressID/FEIBusiness Operations
Colgate-Palmolive785047999MANUFACTURE(35000-171)

Revised: 12/2019
 
Colgate-Palmolive Company