Your browser does not support JavaScript! CREST SENSITIVITY (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]
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CREST SENSITIVITY (potassium nitrate and sodium fluoride) paste, dentifrice
[Procter & Gamble Manufacturing Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredientsPurpose
Potassium nitrate 5%Toothpaste for sensitive teeth
Sodium fluoride 0.243%Toothpaste for cavity prevention

Uses

  • when used regularly, builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • aids in the prevention of cavities

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

  • do not swallow
  • 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 use in children under 12 yrs.

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

Questions?

1-800-492-7378

Dist. by Procter & Gamble,
Cincinnati, OH 45202

www.crest.com

PRINCIPAL DISPLAY PANEL - 116 g Tube Carton

Crest
SENSITIVITY
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 4.1 OZ (116 g)
CLINICALLY PROVEN SENSITIVITY INGREDIENT WITH FLUORIDE

CLINICAL
SENSITIVITY
RELIEF

MAXIMUM STRENGTH*

EXTRA
WHITENING

CLEAN MINT

Principal Display Panel
CREST SENSITIVITY   CLINICAL SENSITIVITY RELIEF
potassium nitrate and sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37000-519
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Potassium nitrate (POTASSIUM CATION) Potassium nitrate0.05 g  in 1 g
Sodium Fluoride (fluoride ion) Sodium Fluoride243 g  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 
titanium dioxide 
FD&C BLUE NO. 1 
Product Characteristics
ColorBLUE (with white specks) Score    
ShapeSize
FlavorPEPPERMINT, SPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-519-021 in 1 CARTON
1NDC:37000-519-0124 g in 1 TUBE
2NDC:37000-519-041 in 1 CARTON
2116 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35508/30/2010
Labeler - Procter & Gamble Manufacturing Company (004238200)

Revised: 2/2011
 
Procter & Gamble Manufacturing Company

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