NDC Code(s) : 35000-176-14, 35000-176-32, 35000-176-48, 35000-176-96, 35000-176-95, 35000-176-78, 35000-176-25, 35000-176-60, 35000-176-33, 35000-176-65, 35000-176-66, 35000-176-21
Packager : Colgate-Palmolive Company

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Colgate Total SF WhiteningStannous Fluoride PASTE, DENTIFRICE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-176
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)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35000-176-141 in 1 CARTON 11/01/2018
139 g in 1 TUBE Type 0: Not a Combination Product
2NDC:35000-176-321 in 1 CARTON 11/01/2018
293 g in 1 TUBE Type 0: Not a Combination Product
3NDC:35000-176-481 in 1 CARTON 11/01/2018
3136 g in 1 TUBE Type 0: Not a Combination Product
4NDC:35000-176-962 in 1 CARTON 11/01/2018
4136 g in 1 TUBE Type 0: Not a Combination Product
5NDC:35000-176-951 in 1 CARTON 11/01/2018
5178 g in 1 TUBE Type 0: Not a Combination Product
6NDC:35000-176-781 in 1 CARTON 11/01/2018
6221 g in 1 TUBE Type 0: Not a Combination Product
7NDC:35000-176-251 in 1 CARTON 15/01/2021
724.9 g in 1 TUBE Type 0: Not a Combination Product
8NDC:35000-176-601 in 1 CARTON 02/12/2021
8170 g in 1 TUBE Type 0: Not a Combination Product
9NDC:35000-176-331 in 1 CARTON 09/11/2021
936.8 g in 1 TUBE Type 0: Not a Combination Product
10NDC:35000-176-652 in 1 CARTON 12/01/2021
10144 g in 1 TUBE Type 0: Not a Combination Product
11NDC:35000-176-661 in 1 CARTON 27/12/2021
11144 g in 1 TUBE Type 0: Not a Combination Product
12NDC:35000-176-211 in 1 CARTON 17/11/2022
1259 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

ADA
Accepted
American
Dental
Association ®

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

Total

24
HR
ANTIBACTERIAL
PROTECTION†

WHITENING

NET WT 6.0 OZ (170 g)
PASTE

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton