NDC Code(s) : 58933-020-03, 58933-020-06, 58933-020-08, 58933-020-85
Packager : Procter & Gamble Manufactura, S. de R.L. de C.V.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Crest Complete Multi-Benefit Sodium fluoride PASTE, DENTIFRICE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58933-020
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 ION1.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL(UNII: 506T60A25R)
WATER(UNII: 059QF0KO0R)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
SODIUM ACID PYROPHOSPHATE(UNII: H5WVD9LZUD)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ALCOHOL(UNII: 3K9958V90M)
XANTHAN GUM(UNII: TTV12P4NEE)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
GLYCERIN(UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM BENZOATE(UNII: OJ245FE5EU)
CETYLPYRIDINIUM CHLORIDE(UNII: D9OM4SK49P)
BENZOIC ACID(UNII: 8SKN0B0MIM)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
Product Characteristics
Color green Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58933-020-031 in 1 CARTON 07/01/2011
176.5 g in 1 TUBE Type 0: Not a Combination Product
2NDC:58933-020-061 in 1 CARTON 07/01/2011
2175 g in 1 TUBE Type 0: Not a Combination Product
3NDC:58933-020-081 in 1 CARTON 07/01/2011
3226 g in 1 TUBE Type 0: Not a Combination Product
4NDC:58933-020-8524 g in 1 TUBE Type 0: Not a Combination Product07/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M021 07/01/2011

LABELER - Procter & Gamble Manufactura, S. de R.L. de C.V.(812807550)

PRINCIPAL DISPLAY PANEL

Crest ®

complete

MULTI-

BENEFIT™

NET WT

8.0 OZ (226 g)

FLUORIDE TOOTHPASTE

WHITENING+

scope ®

minty fresh striped

Principal Display Panel - 226 g Tube Carton