Crest ® Pro-Health™ Sensitvity Whitening Plus Scope®

Drug Labeling and Warnings

Drug Details [pdf]

CREST PRO HEALTH SENSITIVITY WHITENING PLUS SCOPE- sodium fluoride and potassium nitrate paste, dentifrice 
The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Crest ® Pro-Health™
Sensitvity
Whitening Plus Scope®

Drug Facts

Active ingredient

Potassium nitrate 5%
Sodium fluoride 0.243%
(0.14% w/v fluoride ion)

Purposes

Toothpaste for sensitive teeth
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

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 170g 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

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-374
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
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)
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)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-374-06	1 in 1 CARTON	01/01/2019
1		170 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 37000-374-12	2 in 1 CARTON	01/01/2019
2		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	01/01/2019	06/20/2019

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2019

Document Id: 8bc355d3-7eb3-2483-e053-2995a90a608a

34390-5

Set id: 81678f77-d902-a2df-e053-2991aa0aa975

Version: 2

Effective Time: 20190620

 

The Procter & Gamble Manufacturing Company