CREST PRO-HEALTH ADVANCED EXTRA WHITENING- stannous fluoride gel, 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, sodium lauryl sulfate, sodium gluconate, sodium saccharin, trisodium phosphate, carrageenan, xanthan gum, PVP, blue 1

Questions?

1-800-594-4158

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DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 144 g Tube Carton

PROTECTS AGAINST AREAS DENTISTS CHECK MOST. Patented Stannous Fluoride Technology

Crest ® PRO-HEALTH™ ADVANCED

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

EXTRA WHITENING

Removes surface stains & protects against future stains.

CAVITIES GINGIVITIS ACID EROSION* SENSITIVITY PLAQUE TARTAR WHITENING FRESHENS BREATH

NET WT 5.1 OZ (144 g)

INGREDIENTS AND APPEARANCE

CREST PRO-HEALTH ADVANCED  EXTRA WHITENING
stannous fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-938
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
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
WATER (UNII: 059QF0KO0R)
ZINC LACTATE (UNII: 2GXR25858Y)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM GLUCONATE (UNII: R6Q3791S76)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-938-35	1 in 1 CARTON	01/01/2021
1		99 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69423-938-51	1 in 1 CARTON	01/01/2021
2		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 Drug	M021	01/01/2021

Labeler - The Procter & Gamble Manufacturing Company (004238200)