CREST PREMIUM PLUS SENSITIVITY ACTIVE FOAM- sodium fluoride and potassium nitrate paste, dentifrice

Crest Premium Plus by

Drug Labeling and Warnings

Crest Premium Plus 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

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, sodium lauryl sulfate, trisodium phosphate, flavor, cellulose gum, alcohol (0.7%), sodium saccharin, xanthan gum, 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 - 147 g Tube Carton

Crest® plus

PREMIUM

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 5.2 OZ (147 g)

ACTIVE FOAM

+WHITENING

SENSITIVE

MAXIMUM STRENGTH*

SENSITIVITY RELIEF

soothing mint

INGREDIENTS AND APPEARANCE

CREST PREMIUM PLUS  SENSITIVITY ACTIVE FOAM
sodium fluoride and potassium nitrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-995
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	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-995-70	1 in 1 CARTON	01/07/2021
1		198 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 37000-995-52	1 in 1 CARTON	01/07/2021
2		147 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 37000-995-60	1 in 1 CARTON	01/07/2021
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 Drug	M021	01/07/2021

Labeler - The Procter & Gamble Manufacturing Company (004238200)