Label: CREST SENSITIVITY CLINICAL SENSITIVITY RELIEF- potassium nitrate and sodium fluoride paste, dentifrice
- NDC Code(s): 37000-519-01, 37000-519-02, 37000-519-04
- Packager: Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients Purpose Potassium nitrate 5% Toothpaste for sensitive teeth Sodium fluoride 0.243% Toothpaste for cavity prevention
- 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
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.
- 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 1Close
Dist. by Procter & Gamble,
Cincinnati, OH 45202
- PRINCIPAL DISPLAY PANEL - 116 g Tube Carton
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
NET WT 4.1 OZ (116 g)
CLINICALLY PROVEN SENSITIVITY INGREDIENT WITH FLUORIDE
- INGREDIENTS AND APPEARANCE
CREST SENSITIVITY CLINICAL SENSITIVITY RELIEF
potassium nitrate and sodium fluoride paste, dentifrice
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37000-519 Route of Administration DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Potassium nitrate (POTASSIUM CATION) Potassium nitrate 0.05 g in 1 g Sodium Fluoride (fluoride ion) Sodium Fluoride 243 g in 1 g Inactive Ingredients Ingredient Name Strength 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 Color BLUE (with white specks) Score Shape Size Flavor PEPPERMINT, SPEARMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-519-02 1 in 1 CARTON 1 NDC:37000-519-01 24 g in 1 TUBE 2 NDC:37000-519-04 1 in 1 CARTON 2 116 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 08/30/2010 Labeler - Procter & Gamble Manufacturing Company (004238200)