CREST CAVITY PROTECTION REGULAR- sodium fluoride paste, dentifrice

Crest Cavity Protection by

Drug Labeling and Warnings

Crest Cavity Protection by is a Otc medication manufactured, distributed, or labeled by Procter & Gamble Manufactura, S. de R.L. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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 childrenunder 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, sodium phosphate, cellulose gum, carbomer, sodium saccharin, titanium dioxide, blue 1

Questions?

1-800-492-7378

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble,
Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 232 g Tube Carton

HELPS STOP CAVITIES BEFORE THEY START

Crest®

CAVITY

PROTECTION

ADA

Accepted

American

Dental

Association®

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT 8.2 OZ (232 g)

Regular Paste

INGREDIENTS AND APPEARANCE

CREST CAVITY PROTECTION  REGULAR
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58933-005
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
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PHOSPHATE (UNII: SE337SVY37)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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: 58933-005-04	1 in 1 CARTON	02/01/2015
1		181 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58933-005-05	1 in 1 CARTON	02/01/2015
2		232 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 58933-005-08	1 in 1 CARTON	02/01/2015
3	NDC: 58933-005-10	24 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 58933-005-11	1 in 1 CARTON	02/01/2015
4		82 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	02/01/2015

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