CREST 3D WHITE LUXE- 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.

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Crest ®

3D White Luxe ®

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

  • 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 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 (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

PRINCIPAL DISPLAY PANEL - 116 g Tube Carton

Crest®
3DWHITE

LUXE ®

COMPARE TO
SENSODYNE™ *+

DUAL ACTION: SENSITIVITY RELIEF +
POWER OF 3D WHITE

SENSITIVITY

TOOTHPASTE FOR SENSITIVE TEETH
AND CAVITY PREVENTION
ENAMEL SAFE WHITENING

PAMPERING MINT

NET WT 4.1 OZ (116 g)

Principal Display Panel - 116 g Tube Carton
CREST  3D WHITE LUXE
sodium fluoride and potassium nitrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-844
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
Product Characteristics
Colorturquoise (with white specs) Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-844-041 in 1 CARTON02/04/201411/01/2017
1116 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/04/201411/01/2017
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 12/2016
 
The Procter & Gamble Manufacturing Company