CREST PRO-HEALTH ADVANCED BACTERIA PROTECTION- stannous fluoride paste, dentifrice

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active ingredient

Stannous fluoride 0.454%

(0.14% 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

Warning

When using this product do not use for sensitivity longer than four weeks unless
recommended by a dentist.

STOP USE

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

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. of age & 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

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 - 144 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
SENSITIVITY
PLAQUE
TARTAR
WHITENING
FRESHENS
BREATH

DENTIST DESIGNED

CLINICALLY PROVEN

ADVANCED

BACTERIA PROTECTION

PROTECTS AGAINST THE SPREAD OF BACTERIA -
THE ROOT CAUSE OF ISSUES IN THE MOUTH**

INGREDIENTS AND APPEARANCE

CREST PRO-HEALTH  ADVANCED BACTERIA PROTECTION
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-638
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 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: 84126-638-51	1 in 1 CARTON	01/06/2026
1		144 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 84126-638-05	2 in 1 CARTON	01/06/2026
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	01/06/2026

Labeler - The Procter & Gamble Manufacturing Company (004238200)