NDC Code(s) : 37000-879-05, 37000-879-07
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 Stannous Fluoride GEL, DENTIFRICE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37000-879
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)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS(UNII: SX01TZO3QZ)
Product Characteristics
Color blue Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37000-879-051 in 1 CARTON 01/01/2016
1144 g in 1 TUBE Type 0: Not a Combination Product
2NDC:37000-879-071 in 1 CARTON 01/01/2016
2198 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 01/01/2016 12/16/2018

PRINCIPAL DISPLAY PANEL

ADA

Accepted

American

Dental

Association ®

Crest ® PRO-HEALTH™

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

INTENSE PEPPERMINT

CAVITIES | GINGIVITIS | SENSITIVITY | PLAQUE| TARTAR | WHITENING | FRESHENS BREATH

NET WT 5.1OZ (144 g)

879