CREST PRO-HEALTH CLINICAL GUM 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.

----------

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 bristled 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, flavor, trisodium phosphate, sodium gluconate, sodium lauryl sulfate, sodium saccharin, carrageenan, stannous chloride, xanthan gum, polyethylene, titanium dioxide, blue 1 lake, blue 1

Questions?

1-800-594-4158

Dist. by Procter & Gamble, Cincinnati, OH 45202

www.crest.com

PRINCIPAL DISPLAY PANEL - 164g Tube Carton

NEW

Crest ®
PRO-HEALTH ®

CAVITIES
GINGIVITIS
PLAQUE
SENSITIVITY
TARTAR
WHITENING
FRESHENS
BREATH

NET WT 5.8 OZ (164 g)
FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

CLINICAL
GUM
PROTECTION

Helps Prevent Gingivitis &
Helps Reverse Gingivitis
in 4 weeks

CLEAN MINT

Principal Display Panel - 164g Tube Carton
CREST PRO-HEALTH  CLINICAL GUM PROTECTION
stannous fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-561
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 GLUCONATE (UNII: R6Q3791S76)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
STANNOUS CHLORIDE (UNII: 1BQV3749L5)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorWINTERGREEN, PEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-561-0124 g in 1 TUBE; Type 0: Not a Combination Product08/30/201001/29/2017
2NDC:37000-561-021 in 1 CARTON08/30/201001/29/2017
224 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:37000-561-041 in 1 CARTON08/30/201001/29/2017
3113 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:37000-561-051 in 1 CARTON08/30/201001/29/2017
4164 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:37000-561-071 in 1 CARTON08/30/201001/29/2017
5218 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/30/201001/29/2017
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 12/2016
 
The Procter & Gamble Manufacturing Company