CREST PRO HEALTH ENAMEL REPAIR AND GUM ADVANCED WHITENING- 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

Warning

Keep out of reach of children under 12 yrs. of age. 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. 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 12 yrs. of age: ask a dentist

KEEP OUT OF REACH OF CHILDREN

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

water, sorbitol, hydrated silica, sodium
lauryl sulfate, sodium gluconate, flavor, carrageenan, sodium citrate,
xanthan gum, zinc citrate, sodium saccharin, 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 - 104 g tube in carton

ADA Accepted

American Dental Association

CREST

PRO HEALTH

FLUORIDE TOOTHPASTE FOR ANTICAVITY AND ANTIGINGIVITIS

ENAMEL REPAIR

AND GUM

Helps reverse early gum damage in 2 weeks* and strengthens weakened enamel

PREVENTS HARMFUL OXIDANTS

BY REVERSING GINGIVITIS

ACVANCED WHITENING

NET WT 3.7 OZ (104 g)

INGREDIENTS AND APPEARANCE

CREST PRO HEALTH  ENAMEL REPAIR AND GUM ADVANCED WHITENING
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-766
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
SUCRALOSE (UNII: 96K6UQ3ZD4)
STANNOUS CHLORIDE (UNII: 1BQV3749L5)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM GLUCONATE (UNII: R6Q3791S76)
XANTHAN GUM (UNII: TTV12P4NEE)
ZINC CITRATE (UNII: K72I3DEX9B)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITOL (UNII: 506T60A25R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

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: 69423-766-37	1 in 1 CARTON	02/15/2023
1		104 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69423-766-26	1 in 1 CARTON	02/15/2023
2		73 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 69423-766-28	1 in 1 CARTON	02/08/2023
3		79 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 69423-766-41	1 in 1 CARTON	02/08/2023
4		116 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 69423-766-48	1 in 1 CARTON	02/08/2023
5		136 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	02/08/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)