CREST CAVITY PROTECTION REGULAR- sodium fluoride paste, dentifrice

Crest Cavity Protection Regular by

Drug Labeling and Warnings

Crest Cavity Protection Regular by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

helps protect teeth and roots against cavities

Warnings

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

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, flavor, cellulose gum, sodium phosphate, carbomer, sodium saccharin, titanium dioxide, blue 1

Questions?

1-800-492-7378

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble, Cincinnati OH 45202

www.crest.com

PRINCIPAL DISPLAY PANEL - 161 g Carton

HELPS STOP CAVITIES BFORE THEY START

Crest®

ADA
ACCEPTED
American
Dental
Association®

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT 5.7 OZ (161 g)

CAVITY
PROTECTION

Regular Paste

INGREDIENTS AND APPEARANCE

CREST CAVITY PROTECTION REGULAR 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-005
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PHOSPHATE (UNII: SE337SVY37)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-005-01	2.5 g in 1 POUCH; Type 0: Not a Combination Product	08/02/1984
2	NDC: 37000-005-03	1 in 1 CARTON	08/02/1984	12/01/2021
2		130 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 37000-005-04	1 in 1 CARTON	08/02/1984	12/01/2021
3		181 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 37000-005-05	1 in 1 CARTON	08/02/1984
4		232 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 37000-005-10	1 in 1 CARTON	08/02/1984
5	NDC: 37000-005-08	24 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 37000-005-09	170 g in 1 TUBE; Type 0: Not a Combination Product	08/02/1984	06/08/2018
7	NDC: 37000-005-13	2 in 1 CARTON	08/02/1984	12/01/2021
7		181 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC: 37000-005-20	3 in 1 CELLO PACK	08/02/1984	12/01/2021
8		1 in 1 CARTON
8		181 g in 1 TUBE; Type 0: Not a Combination Product
9	NDC: 37000-005-02	1 in 1 CARTON	01/01/2015	12/01/2021
9		83 g in 1 TUBE; Type 0: Not a Combination Product
10	NDC: 37000-005-29	1 in 1 CARTON	08/02/1984	12/01/2021
10		82 g in 1 TUBE; Type 0: Not a Combination Product
11	NDC: 37000-005-24	1 in 1 CARTON	09/10/2019
11		68 g in 1 TUBE; Type 0: Not a Combination Product
12	NDC: 37000-005-42	1 in 1 CARTON	09/10/2019
12		119 g in 1 TUBE; Type 0: Not a Combination Product
13	NDC: 37000-005-57	1 in 1 CARTON	09/10/2019
13		161 g in 1 TUBE; Type 0: Not a Combination Product
14	NDC: 37000-005-11	2 in 1 CARTON	09/10/2019
14		161 g in 1 TUBE; Type 0: Not a Combination Product
15	NDC: 37000-005-90	3 in 1 CELLO PACK	09/10/2019
15		1 in 1 CARTON
15		161 g in 1 TUBE; Type 0: Not a Combination Product
16	NDC: 37000-005-99	4 in 1 CELLO PACK	09/10/2019
16		1 in 1 CARTON
16		161 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	08/02/1984

Labeler - The Procter & Gamble Manufacturing Company (004238200)