CREST PRO-HEALTH ADVANCED MAX CAVITY AND EROSION PREVENTION- 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, 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

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.

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 - 116 g tube in carton

Crest

Pro-Health

NET WT

5.1 OZ (144 g)

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

CAVITIES

GINGIVITIS

ENAMEL

PLAQUE

WHITENING

FRESHENS

BREATH

ADVANCED

MAX CAVITY

+ EROSION PREVENTION

DENTIST DESIGNED

CLINICALLY PROVEN

HELPS STOP CAVITIES

BEFORE THEY START

24h

INGREDIENTS AND APPEARANCE

CREST PRO-HEALTH  ADVANCED MAX CAVITY AND EROSION PREVENTION
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-624
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
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SUCRALOSE (UNII: 96K6UQ3ZD4)
STANNOUS CHLORIDE (UNII: 1BQV3749L5)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM GLUCONATE (UNII: R6Q3791S76)

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: 84126-624-51	1 in 1 CARTON	01/01/2024
1		144 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 84126-624-02	2 in 1 CELLO PACK	01/01/2024
2		1 in 1 CARTON
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	01/01/2024

Labeler - The Procter & Gamble Manufacturing Company (004238200)