CREST PRO-HEALTH SENSITIVE AND GUM ALL DAY 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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Purposes

Anticavity, antigingivitis, antisensitivity 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
• 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.: 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

Apply full brush head of paste. First brush sensitive areas for 30 seconds and finish brushing the rest of the mouth thoroughly.

Inactive ingredients

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

Questions?

1-800-594-4158

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 104 g Tube Carton

ADA Accepted

American Dental Association

Crest

PRO-HEALTH

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

SENSITIVE AND GUM

Starts soothing immediately for lasting relief within days & strengthens gums*

PREVENTS HARMFUL OXIDANTS

BY REVERSING GINGIVITIS

ALL DAY PROTECTION*

NET WT 3.7 OZ (104 g)

INGREDIENTS AND APPEARANCE

CREST PRO-HEALTH  SENSITIVE AND GUM ALL DAY PROTECTION
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-765
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)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM GLUCONATE (UNII: R6Q3791S76)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
ZINC CITRATE (UNII: K72I3DEX9B)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STANNOUS CHLORIDE (UNII: 1BQV3749L5)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: 69423-765-37	1 in 1 CARTON	02/16/2023
1		104 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69423-765-16	1 in 1 CELLO PACK	02/16/2023	07/24/2025
2		1 in 1 CARTON
2		104 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 69423-765-85	1 in 1 CARTON	04/01/2024
3		24 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 69423-765-28	1 in 1 CARTON	02/16/2023	05/01/2023
4		79 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 69423-765-41	1 in 1 CARTON	02/16/2023
5		116 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 69423-765-46	1 in 1 CARTON	02/16/2023
6		130 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 69423-765-48	1 in 1 CARTON	02/16/2023
7		136 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC: 69423-765-52	1 in 1 CARTON	02/16/2023
8		147 g in 1 TUBE; Type 0: Not a Combination Product
9	NDC: 69423-765-03	3 in 1 CARTON	01/01/2023
9		136 g in 1 TUBE; Type 0: Not a Combination Product
10	NDC: 69423-765-33	3 in 1 CELLO PACK	01/01/2023
10		1 in 1 CARTON
10		104 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	01/01/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)