OTC Medication Information: Crest 3DWhite Whitening Therapy Sensitivity Care

CREST 3DWHITE WHITENING THERAPY SENSITIVITY CARE- sodium fluoride and potassium nitrate 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.

Drug Facts

Active ingredient

Potassium Nitrate 5%

Sodium fluoride 0.243% (0.14% w/v fluoride ion)

Purposes

Toothpaste for sensitive teeth

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 longer 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 bristle 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 (0.7%), polysorbate 80, sodium saccharin, sodium benzoate, cetylpyridinium Chloride, benzoic acid, xanthan gum, titanium dioxide

Questions?

1-800-492-7378

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL — 116 g Tube Carton

Crest ®

3D WHITE

TOOTHPASTE FOR SENSITIVE

TEETH AND CAVITY PREVENTION

WHITENING

THERAPY

SENSITIVITY CARE

NET WT 4.1 OZ (116g)

400
(click image for full-size original)
CREST 3DWHITE WHITENING THERAPY SENSITIVITY CARE
potassium nitrate, sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-456
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.4 mg in 1 g
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
GLYCERIN
HYDRATED SILICA
SORBITOL
CARBOXYMETHYLCELLULOSE SODIUM
POLYSORBATE 80
WATER
SODIUM LAURYL SULFATE
SODIUM BENZOATE
CETYLPYRIDINIUM CHLORIDE
SACCHARIN SODIUM
XANTHAN GUM
TITANIUM DIOXIDE
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS
BENZOIC ACID
Product Characteristics
Color white Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37000-456-41 1 TUBE in 1 CARTON contains a TUBE
1 116 g in 1 TUBE This package is contained within the CARTON (37000-456-41)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 07/12/2017
Labeler — The Procter & Gamble Manufacturing Company (004238200)

Revised: 05/2023 The Procter & Gamble Manufacturing Company

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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