LORNAMEAD NATURAL WHITE- fluoride paste, dentifrice

Lornamead by

Drug Labeling and Warnings

Lornamead by is a Otc medication manufactured, distributed, or labeled by Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

Sodium fluoride 0.24% (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

WARNINGS

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

DOSAGE & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

LORNAMEAD  NATURAL WHITE
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62721-0470
Route of Administration	DENTAL

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)