NDC Code(s) : 35000-023-60, 35000-023-34, 35000-023-46
Packager : Colgate-Palmolive Company

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Colgate Sensitive plus WhiteningPOTASSIUM NITRATE and SODIUM FLUORIDE PASTE, DENTIFRICE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-023
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM NITRATE(UNII: RU45X2JN0Z)
(NITRATE ION - UNII:T93E9Y2844) 		POTASSIUM NITRATE50 mg in 1 g
SODIUM FLUORIDE(UNII: 8ZYQ1474W7)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION1.1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
SORBITOL(UNII: 506T60A25R)
POLYETHYLENE GLYCOL 600(UNII: NL4J9F21N9)
METHYL VINYL ETHER AND MALEIC ACID COPOLYMER (1750000 WAMW)(UNII: 9F20VSM0VU)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
POLOXAMER 407(UNII: TUF2IVW3M2)
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE(UNII: B70850QPHR)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(UNII: K679OBS311)
XANTHAN GUM(UNII: TTV12P4NEE)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color BLUE Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35000-023-601 in 1 CARTON 25/02/2019
1170 g in 1 TUBE Type 0: Not a Combination Product
2NDC:35000-023-342 in 1 CARTON 25/02/2019
2170 g in 1 TUBE Type 0: Not a Combination Product
3NDC:35000-023-461 in 1 CARTON 15/06/2020
3130 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 M022 02/25/2019

LABELER - Colgate-Palmolive Company(001344381)

PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity Toothpaste for Sensitive Teeth

MAXIMUM STRENGTH*

Sensitive

WHITENING

Recyclable
Tube

RELIEVES & WHITENS

  • ✓CLINICALLY PROVEN SENSITIVITY RELIEF
  • ✓SUPERIOR STAIN REMOVAL†

NET WT 6.0 OZ (170 g)

FRESH MINT
gel

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton