Crest ® Pro-Health™ Sensitivity Complete Protection

Drug Labeling and Warnings

Drug Details [pdf]

CREST PRO HEALTH SENSITVITY COMPLETE PROTECTION- stannous fluoride paste, 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™
Sensitivity
Complete Protection

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, zinc lactate, water, flavor, trisodium phosphate, sodium lauryl sulfate, sodium gluconate, carrageenan, sodium saccharin, xanthan gum, blue 1

Questions?

1-800-492-7378

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Crest®
PRO-HEALTH
SENSITIVITY

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

NET WT 6.0 OZ (170 g)


REPAIRS* PAINFUL SENSITIVITY

PREVENTS FUTURE SENSITIVITY

COMPLETE

PROTECTION

SMOOTH MINT
BUILDS A THERAPEUTIC & PROTECTIVE LAYER

213

CREST PRO HEALTH SENSITVITY  COMPLETE PROTECTION
stannous fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37000-213
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37000-213-601 in 1 CARTON01/01/2019
1170 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/201906/20/2019
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2019
Document Id: 8bc355d3-7ea4-2483-e053-2995a90a608a
Set id: 81292faa-06ca-037f-e053-2a91aa0aa192
Version: 2
Effective Time: 20190620
 
The Procter & Gamble Manufacturing Company