CREST PRO-HEALTH ADVANCED- stannous fluoride paste, dentifrice

Crest Pro-Health Advanced by

Drug Labeling and Warnings

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

Drug Details [pdf]

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Drug Facts

Active ingredient

Stannous fluoride 0.454% (0.16% 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

Inactive ingredients

glycerin, hydrated silica, sodium hexametaphosphate, propylene glycol, PEG-6, water, zinc lactate, flavor, trisodium phosphate, sodium gluconate, sodium lauryl sulfate, carrageenan, sodium saccharin, stannous chloride, xanthan gum, titanium dioxide, mica, blue 1

Questions?

1-800-594-4158

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DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 99 g Tube Carton

DEEP CLEANING FORMULA

Crest ®PRO-HEALTH ™

ADVANCED

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

GUM PROTECTION

CAVITIES | GINGIVITIS | ACID EROSION*** | SENSITIVITY PLAQUE | TARTAR | WHITENING | FRESHENS BREATH

NET WT 3.5 OZ (99 g)

INGREDIENTS AND APPEARANCE

CREST PRO-HEALTH ADVANCED 
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-880
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ZINC LACTATE (UNII: 2GXR25858Y)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM GLUCONATE (UNII: R6Q3791S76)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
STANNOUS CHLORIDE (UNII: 1BQV3749L5)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MICA (UNII: V8A1AW0880)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-880-01	1 in 1 CARTON	12/29/2016
1		24 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 37000-880-03	1 in 1 CARTON	12/29/2016
2		99 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 37000-880-05	1 in 1 CARTON	12/29/2016
3		144 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 37000-880-07	2 in 1 CELLO PACK	12/29/2016	06/17/2019
4		1 in 1 CARTON
4		99 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 37000-880-10	2 in 1 CELLO PACK	12/29/2016
5		1 in 1 CARTON
5		144 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 37000-880-15	3 in 1 CELLO PACK	12/29/2016
6		1 in 1 CARTON
6		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 final	part355	12/29/2016

Labeler - The Procter & Gamble Manufacturing Company (004238200)