CREST  SENSI-RELIEF- sodium fluoride and potassium nitrate paste, dentifrice 
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®
Sensi-Relief™

Drug Facts

Active ingredientsPurpose
Potassium nitrate 5%Toothpaste for sensitive teeth
Sodium fluoride 0.243% (0.14% w/v fluoride ion)Toothpaste for cavity prevention

Uses

Warnings

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

Stop use and ask a dentist if problem lasts or gets worse. 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

Inactive ingredients

water, hydrated silica, glycerin, sorbitol, trisodium phosphate, sodium lauryl sulfate, flavor, cellulose gum, alcohol (1.09%), xanthan gum, sodium saccharin, polysorbate 80, sodium benzoate, cetylpyridinium chloride, benzoic acid, polyethylene, titanium dioxide, blue 1 lake, yellow 10 lake, iron oxides, blue 1, yellow 5

Questions?

1-800-492-7378

Dist. by Procter & Gamble, Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 116 g Tube Carton

SAME CLINICALLY PROVEN ACTIVE INGREDIENT AS SENSODYNE™

Crest®

SENSI • RELIEF™

NET WT 4.1 OZ (116 g)
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

MAXIMUM STRENGTH*
SENSITIVITY RELIEF

WHITENING

Principal Display Panel - 116 g Tube Carton
CREST   SENSI-RELIEF
sodium fluoride and potassium nitrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37000-850
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Fluoride Ion1.4 mg  in 1 g
Potassium Nitrate (NITRATE ION) Potassium Nitrate50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
GLYCERIN 
SORBITOL 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM 
ALCOHOL 
XANTHAN GUM 
SACCHARIN SODIUM 
POLYSORBATE 80 
SODIUM BENZOATE 
CETYLPYRIDINIUM CHLORIDE 
BENZOIC ACID 
HIGH DENSITY POLYETHYLENE 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
D&C YELLOW NO. 10 
FERRIC OXIDE RED 
FD&C YELLOW NO. 5 
Product Characteristics
ColorGREEN (with dark green gel) Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-850-041 in 1 CARTON
1116 g in 1 TUBE
2NDC:37000-850-011 in 1 CARTON
224 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35611/13/2013
Labeler - Procter & Gamble Manufacturing Company (004238200)

Revised: 12/2013
Document Id: 7b43444e-0807-4f69-a49a-27178ecfbb92
Set id: fdbcf975-54d1-4c89-9296-840823935eb3
Version: 1
Effective Time: 20131210
 
Procter & Gamble Manufacturing Company