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 Products, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Inactive ingredients

water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, xanthan gum, flavor, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1

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 twice a day (morning and evening), and not more than 3 tims a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimiza swallowing. Spit out after brushing.
• children under 12 years of age: Consult a dentist or doctor.

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, if irritation occurs discontinue use.

Stop use and ask a dentist if

• the problem persists or worsen
• Sensitive teeth may indicate a resious 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 burshing is accidentally swallowed, get medical help or contact a Poison Center right away.

Active ingredients / Purpose

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

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

DOSAGE & ADMINISTRATION

adults and children 12 years of age and older: 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCO ASSOCIATES LLC  MAXIMUM STRENGTH
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-364
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SUCRALOSE (UNII: 96K6UQ3ZD4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

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: 36800-364-10	1 in 1 CARTON	06/26/2025
1		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 Drug	M022	06/26/2025

Labeler - Topco Associates LLC (006935977)

Registrant - Lornamead Products (119559733)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	manufacture(36800-364) , pack(36800-364)