CREST PRO-HEALTH MAXIMUM CAVITY PROTECTION- stannous fluoride paste, dentifrice

Crest Pro-Health by

Drug Labeling and Warnings

Crest Pro-Health by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Stannous fluoride 0.454%

(0.15% w/v fluoride ion)

Purposes

Anticavity, antigingivitis toothpaste

Uses

• aids in the prevention of cavities
• helps prevent gingivitis
• helps interfere with the harmful effects of plaque associated with gingivitis
• helps control plaque bacteria that contribute to the development of gingivitis
  

WARNINGS

Keep out of reach of children under 6 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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

Stop use and ask a dentist if the sensitivity problem persists or worsens. 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

• adults and children 6 yrs. of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
• do not swallow
• children under 6 yrs. of age: ask a dentist
  

Other information

• products containing stannous fluoride may produce surface staining of the teeth
• adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
• this Crest is specially formulated to help prevent staining
• see your dentist regularly

Inactive ingredients

glycerin, sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium citrate, flavor, sodium gluconate, carrageenan, xanthan gum, sodium saccharin, cocamidopropyl betaine, sodium hydroxide, stannous chloride, sucralose, titanium dioxide

Questions?

1-800-594-4158

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

Principal Display Panel - 116 g tube in carton

Crest

Pro-Health

NET WT

4.3 OZ (121 g)

FLUORIDE TOOTHPASTE FOR ANTICAVITY AND ANTIGINGIVITIS

CAVITIES

GUM

ENAMEL

PLAQUE

WHITENS

FRESHENS

BREATH

MAXIMUM

CAVITY

PROTECTION

HELPS STOP CAVITIES

BEFORE THEY START

12h

INGREDIENTS AND APPEARANCE

CREST PRO-HEALTH  MAXIMUM CAVITY PROTECTION
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-608
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SUCRALOSE (UNII: 96K6UQ3ZD4)
STANNOUS CHLORIDE (UNII: 1BQV3749L5)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM GLUCONATE (UNII: R6Q3791S76)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-608-43	1 in 1 CARTON	09/01/2023
1		121 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 84126-608-26	1 in 1 CARTON	09/01/2023
2		73 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 84126-608-04	2 in 1 CARTON	09/01/2023
3		121 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 84126-608-03	3 in 1 CARTON	09/01/2023
4		121 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 84126-608-85	24 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	09/01/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)