CREST TARTAR PROTECTION- sodium fluoride paste, dentifrice

Crest Tartar Protection by

Drug Labeling and Warnings

Crest Tartar Protection 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 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

sorbitol, water, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, sodium hydroxide, flavor, xanthan gum, sodium saccharin, cellulose gum, carbomer, titanium dioxide, blue 1

Questions?

1-800-492-7378

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble, Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 161 g Tube Carton

HELPS PREVENT TARTAR & CAVITIES

Crest®

ADA

Accepted

American

Dental

Association ®

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT 5.7 OZ (161 g)

TARTAR
PROTECTION

Regular Paste

INGREDIENTS AND APPEARANCE

CREST TARTAR PROTECTION 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-008
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
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-008-02	1 in 1 CARTON	11/06/1992	12/01/2021
1		82 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 37000-008-03	1 in 1 CARTON	11/06/1992	12/01/2021
2		130 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 37000-008-04	1 in 1 CARTON	11/06/1992	12/01/2021
3		181 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 37000-008-24	1 in 1 CARTON	09/01/2019
4		68 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 37000-008-42	1 in 1 CARTON	09/01/2019
5		119 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 37000-008-57	1 in 1 CARTON	09/01/2019
6		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	11/06/1992

Labeler - The Procter & Gamble Manufacturing Company (004238200)