CREST PRO-HEALTH SENSITIVITY RELIEF- sodium fluoride and potassium nitrate paste, dentifrice

Drug Labeling and Warnings

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 productdo not use longer than four weeks unless recommended by a dentist.

Stop use and ask a dentist ifproblem 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

• 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 swallow
• 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, cetylpyridinium chloride, 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

NET WT

5.1 0Z (144 g)

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PROTECTION

DENTIST DESIGNED

CLINICALLY PROVEN

+ WHITENING

SENSITIVITY RELIEF

Maximum strength** sensitivity relief

MINTY FRESH SCOPE

INGREDIENTS AND APPEARANCE

CREST PRO-HEALTH  SENSITIVITY RELIEF
sodium fluoride and potassium nitrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-639
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
CELLULOSE GUM (UNII: K679OBS311)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
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)
ALCOHOL (UNII: 3K9958V90M)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

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: 84126-639-51	1 in 1 CARTON	01/06/2026
1		144 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 84126-639-05	2 in 1 CARTON	01/06/2026
2		144 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	01/06/2026

Labeler - The Procter & Gamble Manufacturing Company (004238200)