CREST PRO-HEALTH SENSITIVIVE AND ENAMEL SHIELD- stannous fluoride gel, dentifrice 
The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Crest ® Pro-Health™

Sensitive & Enamel Shield

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

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

water, sorbitol, hydrated silica, sodium lauryl sulfate, carrageenan, sodium gluconate, flavor, xanthan gum, zinc citrate, stannous chloride, sodium hydroxide, sodium

Questions?

1-800-594-4158

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 130 g Tube Carton

SMOOTH FORMULA

Crest® PRO-HEALTH™

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

SENSITIVE & ENAMEL SHIELD

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

NET WT 4.6 OZ (130 g)

468

CREST PRO-HEALTH  SENSITIVIVE AND ENAMEL SHIELD
stannous fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-468
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
STANNOUS CHLORIDE (UNII: 1BQV3749L5)  
ZINC CITRATE (UNII: K72I3DEX9B)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
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
ColorblueScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-468-331 in 1 CARTON11/02/201606/08/2018
193 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:37000-468-461 in 1 CARTON11/02/201606/08/2018
2130 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:37000-468-922 in 1 CELLO PACK11/02/201606/08/2018
31 in 1 CARTON
3130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/02/201606/08/2018
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2018
Document Id: 6e23c9d9-81ff-00b0-e053-2991aa0a9bfc
Set id: 5487ab10-4742-06f8-e054-00144ff88e88
Version: 2
Effective Time: 20180608
 
The Procter & Gamble Manufacturing Company