NATURAL WHITE- sodium fluoride paste, dentifrice 
Lornamead

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5010474 NW Enamel Guard

Potassium nitrate 5%

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

Antihypersensitivity

Anticavity

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

When using this product, if irritation occurs discontinue use.

Stop use and ask a dentis if * the problem persists or worsens. Sensitive teeth my indicate a serious problem that may need prompt care by a dentist. * pain/sensitivity still persists after 4 weeks of use.

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.

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), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. * Minimize swallowing * Spit out after brushing * Children under 12 years of age: consult a dentist or doctor.

store below 30°C (86°F)

water, hydrated silica, sorbitol, glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

Carton R3

NATURAL WHITE 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62721-0474
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62721-0474-91 in 1 CARTON04/08/2022
176.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02204/08/2022
Labeler - Lornamead (126440440)
Registrant - Lornamead (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead080046418manufacture(62721-0474) , pack(62721-0474)

Revised: 2/2024
 
Lornamead