NDC Code(s) : 35000-175-32, 35000-175-48, 35000-175-96, 35000-175-95, 35000-175-78, 35000-175-60, 35000-175-65, 35000-175-66
Packager : Colgate-Palmolive Company

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Colgate Total SF Whitening GelStannous Fluoride PASTE, DENTIFRICE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-175
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STANNOUS FLUORIDE(UNII: 3FTR44B32Q)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION1.1 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(UNII: K679OBS311)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
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)
Product Characteristics
Color BLUE, WHITE Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35000-175-321 in 1 CARTON 11/01/2018
193 g in 1 TUBE Type 0: Not a Combination Product
2NDC:35000-175-481 in 1 CARTON 11/01/2018
2136 g in 1 TUBE Type 0: Not a Combination Product
3NDC:35000-175-962 in 1 CARTON 11/01/2018
3136 g in 1 TUBE Type 0: Not a Combination Product
4NDC:35000-175-951 in 1 CARTON 11/01/2018
4178 g in 1 TUBE Type 0: Not a Combination Product
5NDC:35000-175-781 in 1 CARTON 11/01/2018
5221 g in 1 TUBE Type 0: Not a Combination Product
6NDC:35000-175-601 in 1 CARTON 02/10/2021
6170 g in 1 TUBE Type 0: Not a Combination Product
7NDC:35000-175-652 in 1 CARTON 12/01/2021
7144 g in 1 TUBE Type 0: Not a Combination Product
8NDC:35000-175-661 in 1 CARTON 27/12/2021
8144 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 DRUG M021 11/01/2018

LABELER - Colgate-Palmolive Company(001344381)

PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity, Antigingivitis and Antisensitivity Toothpaste

✓CAVITIES ✓PLAQUE ✓GINGIVITIS ✓ENAMEL
✓TARTAR ✓FRESH BREATH ✓WHITENS ✓SENSITIVITY RELIEF

Total

24
HR
ANTIBACTERIAL
PROTECTION†

WHITENING

NET WT 5.1 OZ (144 g)

GEL

PRINCIPAL DISPLAY PANEL - 144 g Tube Carton