NDC Code(s) : 37000-873-04, 37000-873-08, 37000-873-12, 37000-873-85, 37000-873-36, 37000-873-39, 37000-873-27, 37000-873-52, 37000-873-24, 37000-873-35, 37000-873-93, 37000-873-78
Packager : The Procter & Gamble Manufacturing Company

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Crest 3D White sodium fluoride PASTE, DENTIFRICE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-873
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE(UNII: 8ZYQ1474W7)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION1.6 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE OXIDE 1000000(UNII: HZ58M6D839)
POLYETHYLENE OXIDE 900000(UNII: 16P9295IIL)
XANTHAN GUM(UNII: TTV12P4NEE)
SUCRALOSE(UNII: 96K6UQ3ZD4)
MICA(UNII: V8A1AW0880)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GLYCERIN(UNII: PDC6A3C0OX)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
SODIUM POLYMETAPHOSPHATE(UNII: P1BM4ZH95L)
WATER(UNII: 059QF0KO0R)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS(UNII: SX01TZO3QZ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
CARRAGEENAN(UNII: 5C69YCD2YJ)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
Product Characteristics
Color white Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37000-873-041 in 1 CARTON 07/06/2015
1116 g in 1 TUBE Type 0: Not a Combination Product
2NDC:37000-873-082 in 1 CELLO PACK 07/06/2015
21 in 1 CARTON 07/06/2015
2116 g in 1 TUBE Type 0: Not a Combination Product
3NDC:37000-873-123 in 1 CELLO PACK 07/06/2015
31 in 1 CARTON 07/06/2015
3116 g in 1 TUBE Type 0: Not a Combination Product
4NDC:37000-873-851 in 1 CARTON 07/06/2015
424 g in 1 TUBE Type 0: Not a Combination Product
5NDC:37000-873-3624 g in 1 TUBE Type 0: Not a Combination Product07/06/2015
6NDC:37000-873-391 in 1 CARTON 01/05/2021
6110 g in 1 TUBE Type 0: Not a Combination Product07/06/2015
7NDC:37000-873-271 in 1 CARTON 01/05/2021
776 g in 1 TUBE Type 0: Not a Combination Product07/06/2015
8NDC:37000-873-521 in 1 CARTON 02/11/2021
8147 g in 1 TUBE Type 0: Not a Combination Product07/06/2015
9NDC:37000-873-241 in 1 CARTON 07/06/2015
968 g in 1 TUBE Type 0: Not a Combination Product07/06/2015
10NDC:37000-873-351 in 1 CARTON 07/06/2015
1099 g in 1 TUBE Type 0: Not a Combination Product07/06/2015
11NDC:37000-873-933 in 1 CELLO PACK 07/06/2015
111 in 1 CARTON 07/06/2015
11110 g in 1 TUBE Type 0: Not a Combination Product07/06/2015
12NDC:37000-873-781 in 1 CARTON 07/06/2015
12221 g in 1 TUBE Type 0: Not a Combination Product07/06/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M021 07/06/2015

LABELER - The Procter & Gamble Manufacturing Company(004238200)

PRINCIPAL DISPLAY PANEL

12 HR STAIN PROTECTION

Crest ®
3D WHITE™
FLUORIDE ANTICAVITYTOOTHPASTE

NET WT 4.1 OZ (116 g)

OUR MOST ADVANCED

WHITENING TECHNOLOGY*

BRILLIANCE

+ ADVANCED STAIN PROTECTION

ENAMEL SAFE WHITENING VIBRANT PEPPERMINT

crest-01