COLGATE TOTAL SF ADVANCED WHITENING- stannous fluoride paste, dentifrice

Colgate Total SF Advanced Whitening by

Drug Labeling and Warnings

Colgate Total SF Advanced Whitening by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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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

Total™SF
WHOLE MOUTH HEALTH

ADVANCED
WHITENING

Paste

INGREDIENTS AND APPEARANCE

COLGATE TOTAL SF ADVANCED WHITENING 
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-171
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 FORM (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
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-171-25	1 in 1 CARTON	11/01/2018	01/01/2022
1		24.9 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-171-93	1 in 1 CARTON	11/01/2018	01/01/2022
2		96 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 35000-171-47	1 in 1 CARTON	11/01/2018	01/01/2022
3		144 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 35000-171-65	2 in 1 CARTON	11/01/2018	01/01/2022
4		144 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 35000-171-64	1 in 1 CARTON	11/01/2018	01/01/2022
5		181 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	11/01/2018

Labeler - Colgate-Palmolive Company (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive		785047999	MANUFACTURE(35000-171)