THE NATURAL DENTIST SENSITIVITY- fluoride paste, dentifrice 
Caldwell Consumer Health LLC

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.

----------

The Natural Dentist Sensitivity Toothpaste

Active ingredient

Potassium nitrate 5% w/w................................................... Antihypersensitivity

Sodium fluoride 0.24% w/w (0.15% w/v fluoride ion)...............Anticavity

Uses

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

Stop use and ask a dentist if the sensitivity persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Do not use if safety seal is broken.

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

Adults and children 12 years of age and older: Brush teeth thoroughly after meals, at least twice a day or as directed by a dentist. Make sure to brush all sensitive areas of the teeth.

Children under 12 years of age: Consult a dentist or physician.

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: ask a dentist.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive ingredients

Hydrated Silica, Glycerin, Sorbitol, Water, Xylitol, Aloe Barbadensis Leaf Juice, Cellulose Gum, Cocamidopropyl Betaine, Sodium Cocoyl Glycinate, Thaumatococcus danielli Fruit Extract, Titanium Dioxide, Xanthan Gum, Citrus grandis (Grapefruit) Seed Extract, Flavor

mm1.jpg

Tube Label

THE NATURAL DENTIST  SENSITIVITY
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34362-0230
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
XYLITOL (UNII: VCQ006KQ1E)  
THAUMATOCOCCUS DANIELLII FRUIT (UNII: 993MIP2UR1)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CITRUS PARADISI SEED (UNII: 12F08874Y7)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINT (Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:34362-0230-1142 g in 1 TUBE; Type 0: Not a Combination Product05/01/201102/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/01/201102/01/2013
Labeler - Caldwell Consumer Health LLC (828558713)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead078584069manufacture(34362-0230) , pack(34362-0230)

Revised: 2/2019
 
Caldwell Consumer Health LLC