Drug Facts

Active ingredient

Sodium fluoride 0.243% (0.16% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

helps protect against cavities

Warning

Keep out of reach of children under 6 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
- do not swallow
- to minimize swallowing use a pea-sized amount in children under 6
- supervise children's brushing until good habits are established
children under 2 yrs.: ask a dentist

Inactive ingredients

glycerin, hydrated silica, water, propylene glycol, sodium bicarbonate, tetrasodium pyrophosphate, sorbitol, PEG-12, flavor, sodium hydroxide, sodium lauryl sulfate, sodium saccharin, poloxamer 407, xanthan gum, cellulose gum, calcium peroxide, titanium dioxide, blue 1

Questions?

1-800-492-7378

Dist. by Procter & Gamble, Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 161 g Tube Carton

Crest ®

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT 5.7 OZ (161 g)

BAKING SODA
& PEROXIDE
WHITENING

WITH TARTAR PROTECTION

Fresh Mint

044

CREST BAKING SODA AND PEROXIDE WHITENING WITH TARTAR PROTECTION
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37000-044
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.6 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLOXAMER 407 (UNII: TUF2IVW3M2)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37000-044-07	1 in 1 CARTON	07/01/2013	01/31/2024
1		82 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:37000-044-04	1 in 1 CARTON	07/01/2013	01/31/2024
2		130 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:37000-044-06	1 in 1 CARTON	07/01/2013	12/01/2021
3		181 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:37000-044-08	1 in 1 CARTON	07/01/2013	12/01/2021
4		232 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC:37000-044-13	2 in 1 CARTON	07/01/2013	01/31/2024
5		181 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC:37000-044-24	1 in 1 CARTON	07/01/2019
6		68 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC:37000-044-42	1 in 1 CARTON	07/01/2019
7		119 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC:37000-044-57	1 in 1 CARTON	07/01/2019
8		161 g in 1 TUBE; Type 0: Not a Combination Product
9	NDC:37000-044-82	1 in 1 CARTON	07/01/2019
9		232 g in 1 TUBE; Type 0: Not a Combination Product
10	NDC:37000-044-02	2 in 1 CARTON	07/01/2019
10		161 g in 1 TUBE; Type 0: Not a Combination Product
11	NDC:37000-044-03	3 in 1 CELLO PACK	07/01/2019	01/31/2024
11		161 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	07/01/2013

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Crest ® Baking Soda & Peroxide Whitening with Tartar Protection