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 ingredients Purpose
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 Type HUMAN OTC DRUG Item Code (Source) NDC:37000-850
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 1.4 mg  in 1 g
Potassium Nitrate (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) Potassium Nitrate 50 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
ALCOHOL (UNII: 3K9958V90M)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
Color GREEN (with dark green gel) Score     
Shape Size
Flavor PEPPERMINT Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37000-850-04 1 in 1 CARTON
1 116 g in 1 TUBE
2 NDC:37000-850-01 1 in 1 CARTON
2 24 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part356 11/13/2013
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