NDC Code(s) : 37000-874-01, 37000-874-03, 37000-874-05, 37000-874-07
Packager : The Procter & Gamble Manufacturing Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Crest Pro-Health Advanced Stannous Fluoride PASTE, DENTIFRICE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37000-874
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 ION1.6 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
SODIUM POLYMETAPHOSPHATE(UNII: P1BM4ZH95L)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
WATER(UNII: 059QF0KO0R)
ZINC LACTATE(UNII: 2GXR25858Y)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM GLUCONATE(UNII: R6Q3791S76)
CARRAGEENAN(UNII: 5C69YCD2YJ)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
XANTHAN GUM(UNII: TTV12P4NEE)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37000-874-011 in 1 CARTON 16/09/2015
124 g in 1 TUBE Type 0: Not a Combination Product
2NDC:37000-874-031 in 1 CARTON 16/09/2015
299 g in 1 TUBE Type 0: Not a Combination Product
3NDC:37000-874-051 in 1 CARTON 16/09/2015
3144 g in 1 TUBE Type 0: Not a Combination Product
4NDC:37000-874-071 in 1 CARTON 16/09/2015
4198 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 09/16/2015 12/19/2018

PRINCIPAL DISPLAY PANEL

Crest ®

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

PRO-HEALTH™

ADVANCED

HEALTHIER GUMS AND STRONGER TEETH*

EXTRA WHITENING POWER + FRESHNESS

CAVITIES | GINGIVITIS | SENSITIVITY | PLAQUE

TARTAR | WHITENING | FRESHENS BREATH

NET WT 5.0 OZ (144 g)

874