TOPCO ASSOCIATES LLC MAXIMUM STRENGTH- fluoride paste, dentifrice

Topco Associates LLC by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients / Purpose

Potassium nitrate 5%....................................................Antihypersensitivity

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

Uses

aids in the prevention of dental cavities

WARNINGS

If pain/sensitivity still persists after 4 weeks of use, please visit your dentist. Stop use and see your doctor if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

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 product onto a soft bristle toothbrush. Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.

DOSAGE & ADMINISTRATION

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

Other Information

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

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

TOPCO ASSOCIATES LLC  MAXIMUM STRENGTH
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-481
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	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
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	green	Score
Shape		Size
Flavor	MINT (mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-481-49	1 in 1 CARTON	11/15/2012
1	NDC: 36800-481-42	113 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	01/20/2011

Labeler - Topco Associates LLC (006935977)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		078584069	manufacture(36800-481) , pack(36800-481)