LORNAMEAD NATURAL WHITE- sodium fluoride and potassium nitrate paste, dentifrice 
Lornamead

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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Drug Facts

Active ingredient

Potassium nitrate 5% ................................................... Antisensitivity

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

Uses

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. Stop use and ask a dentist if the sensitivity problem worsens. 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

Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least one 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 swallow

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

Water, Hydrated Silica, Sorbitol, Glycerin, Cocamidopropyl Betaine, PEG-12, Titanium Dioxide, Cellulose Gum, Flavor, Sodium Benzoate, Sodium Saccharin, Red 40

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Carton label

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Tube Label

LORNAMEAD  NATURAL WHITE
fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62721-0470
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.24 g  in 100 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 5.0 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
Product Characteristics
Color pink Score     
Shape Size
Flavor MINT (Vanilla Mint) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62721-0470-9 1 in 1 CARTON
1 NDC:62721-0470-2 128 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 12/01/2012
Labeler - Lornamead (126440440)
Registrant - Lornamead (126440440)
Establishment
Name Address ID/FEI Business Operations
Lornamead 126440440 manufacture(62721-0470) , pack(62721-0470)

Revised: 1/2013
Document Id: e961d00c-5ba3-4b53-8f05-1077d95b4beb
Set id: 9d7d08d7-8ca4-4b05-8b74-3bfa372b1608
Version: 1
Effective Time: 20130110
 
Lornamead