Crest ® Pro-Health™

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]

CREST PRO-HEALTH- 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™

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

Questions?

1-800-594-4158

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 144 g Tube Carton

ADA
Accepted
American
Dental
Association ®

Crest® PRO-HEALTH™

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

ORIGINAL CLEAN MINT

CAVITIES | GINGIVITIS | SENSITIVITY | PLAQUE

TARTAR | WHITENING | FRESHENS BREATH

NET WT 5.1 OZ (144 g)

574

CREST PRO-HEALTH 
stannous fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37000-574
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)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37000-574-041 in 1 CARTON07/25/200602/27/2017
1119 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 37000-574-061 in 1 CARTON07/25/200602/27/2017
2170 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 37000-574-071 in 1 CARTON07/25/200603/04/2017
3221 g in 1 TUBE; Type 0: Not a Combination Product
4NDC: 37000-574-031 in 1 CARTON01/01/2016
4104 g in 1 TUBE; Type 0: Not a Combination Product
5NDC: 37000-574-051 in 1 CARTON01/01/2016
5144 g in 1 TUBE; Type 0: Not a Combination Product
6NDC: 37000-574-701 in 1 CARTON01/01/2016
6198 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/25/200601/21/2019
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2019
Document Id: 8bc54caf-efa7-d6e0-e053-2a95a90abea2
Set id: 0d8be7a8-5e00-49ab-b037-249de583bfad
Version: 3
Effective Time: 20190620
 
The Procter & Gamble Manufacturing Company