CREST SENSITIVITY WHITENING PLUS SCOPE- sodium fluoride and potassium nitrate paste, dentifrice

Crest Sensitivity by

Drug Labeling and Warnings

Crest Sensitivity by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company, Jost Chemical Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Potassium nitrate 5%	Toothpaste for sensitive teeth
Sodium fluoride 0.243% (0.14% w/v fluoride ion)	Toothpaste for cavity prevention

Uses

• when used regularly, builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
• aids in the prevention of cavities

Warnings

When using this product do not use longer than four weeks unless recommended by a dentist.

Stop use and ask a dentist if problem lasts or gets worse. Sensitive teeth may indicate a serious problem that may need prompt care.

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

Directions

• do not swallow
• 12 yrs. & older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
• do not use in children under 12 yrs.

Inactive ingredients

water, hydrated silica, glycerin, sorbitol, trisodium phosphate, sodium lauryl sulfate, flavor, cellulose gum, alcohol (1.09%), xanthan gum, sodium saccharin, polysorbate 80, sodium benzoate, cetylpyridinium chloride, benzoic acid, titanium dioxide, blue 1

Questions?

1-800-492-7378

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble, Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Crest®

PRO-HEALTH

SENSITIVITY

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 6.0 OZ (170 g)

MAXIMUM STRENGTH*
SENSITIVITY RELIEF

WHITENING PLUS

scope ®

MINTY FRESH

INGREDIENTS AND APPEARANCE

CREST SENSITIVITY  WHITENING PLUS SCOPE
sodium fluoride and potassium nitrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-898
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
BENZOIC ACID (UNII: 8SKN0B0MIM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ALCOHOL (UNII: 3K9958V90M)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM BENZOATE (UNII: OJ245FE5EU)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-898-41	1 in 1 CARTON	01/01/2018	06/18/2019
1		116 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 37000-898-06	1 in 1 CARTON	01/01/2018
2		170 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 37000-898-12	2 in 1 CARTON	01/01/2018
3		170 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 not final	part356	01/01/2018

Labeler - The Procter & Gamble Manufacturing Company (004238200)