LORNAMEAD NATURAL WHITE- fluoride paste, dentifrice

Lornamead by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Potassium Nitrate 5% (w/w)

Sodium Fluoride 0.24% (w/w)

PURPOSE

Purpose

Antihypersenstivity

Anticavity

INDICATIONS & USAGE

Use

aids in the prevention of dental cavities

WARNINGS

Warnings

If pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

• 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.

DOSAGE & ADMINISTRATION

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.
• Children under 12 years of age: consult a dentist or doctor.

INACTIVE INGREDIENT

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

STORAGE AND HANDLING

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

SPL UNCLASSIFIED SECTION

Manufactured by:

Lornamead, Inc.

Tonawanda, NY 14150

Made in USA

Comments? Questions?

Email us at: customerservice@lornamead.com

or call 1-877-777-2743

PRINCIPAL DISPLAY PANEL

Natural White

Extreme Sensitive

WHITENING TOOTHPASTE

TARTAR CONTROL

REDUCES SENSITIVITY

FIGHTS CAVITIES

NET WT. 4.5 OZ / 128 g

INGREDIENTS AND APPEARANCE

LORNAMEAD  NATURAL WHITE
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62721-0471
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 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
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, UNSPECIFIED FORM (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: 62721-0471-9	1 in 1 CARTON	12/01/2012
1		128 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/01/2012

Labeler - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(62721-0471)