CREST 3DWHITE WHITENING THERAPY SENSITIVITY CARE- potassium nitrate, sodium fluoride paste, dentifrice

Crest 3DWhite Whitening Therapy by

Drug Labeling and Warnings

Crest 3DWhite Whitening Therapy 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

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 longer 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 (0.7%), polysorbate 80, sodium saccharin, sodium benzoate, cetylpyridinium Chloride, benzoic acid, xanthan gum, titanium dioxide

Questions?

1-800-492-7378

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 116 g Tube Carton

Crest ®

3D WHITE ™

TOOTHPASTE FOR SENSITIVE

TEETH AND CAVITY PREVENTION

WHITENING

THERAPY

SENSITIVITY CARE

NET WT 4.1 OZ (116g)

INGREDIENTS AND APPEARANCE

CREST 3DWHITE WHITENING THERAPY  SENSITIVITY CARE
potassium nitrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-456
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
BENZOIC ACID (UNII: 8SKN0B0MIM)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-456-41	1 in 1 CARTON	07/12/2017
1		116 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	07/12/2017

Labeler - The Procter & Gamble Manufacturing Company (004238200)