CREST PRO-HEALTH DENSIFY PRO INTENSIVE REPAIR- 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, antisensitivity toothpaste

Uses

• aids in the prevention of cavities
• builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

WARNINGS

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 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
• children under 12 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 - 99 g tube in carton

Crest

PRO HEALTH

FLUORIDE TOOTHPASTE FOR ANTICAVITY AND SENSITIVE TEETH

DENSIFY

ACTIVE REPAIR

ACTIVELY REVERSES

EARLY DECAY

TO EXTEND THE LIFE OF TEETH*

INTENSIVE CLEAN

3X DECAY

PRO

PREVENTION SYSTEM

NET WT 0.85 OZ (24g)

INGREDIENTS AND APPEARANCE

CREST PRO-HEALTH  DENSIFY PRO INTENSIVE REPAIR
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-755
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
GLYCINE (UNII: TE7660XO1C)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SUCRALOSE (UNII: 96K6UQ3ZD4)
STANNOUS CHLORIDE (UNII: 1BQV3749L5)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM GLUCONATE (UNII: R6Q3791S76)
POLOXAMER 407 (UNII: TUF2IVW3M2)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)

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: 69423-755-85	1 in 1 CARTON	02/10/2023
1		24 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69423-755-25	1 in 1 CARTON	02/10/2023
2		70 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 69423-755-35	1 in 1 CARTON	02/10/2023
3		99 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 69423-755-46	1 in 1 CARTON	02/10/2023
4		130 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	02/10/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)