LINHART- sodium fluoride toothpaste paste, dentifrice

LINHART by

Drug Labeling and Warnings

LINHART by is a Otc medication manufactured, distributed, or labeled by Nutrix International,LLC, Nutrix, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium Fluoride 0.25%

Purpose

Anticavity

Indications and Usage

Aids in the prevention of dental decay.

Warnings

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach section

Keep out of reach of children under 6 years of age.

Directions

• Adults and Children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
• Instruct children 6 years of age in good brushing and rinsing habits (to minimize swallowing), and and only use a pea size amount.
• Supervise children as necessary until capable of using without supervision.
• Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients

Sorbitol, Water (Purified), Hydrated Silica, Xylitol, Glycerin, Sodium Lauryl Sulfate, Flavor, Titanium Dioxide, Cellulose Gum,Disodium Phosphate, Aloe Barbadensis Leaf Juice, Allantoin, Sodium Saccharin, Theobromine,Bisobolol.

Questions

(212) 599-2397

Primary Packaging Label

Packaging Label - Carton

INGREDIENTS AND APPEARANCE

LINHART 
sodium fluoride toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73333-096
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
THEOBROMINE (UNII: OBD445WZ5P)
XYLITOL (UNII: VCQ006KQ1E)
ALLANTOIN (UNII: 344S277G0Z)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73333-096-02	1 in 1 CARTON	09/25/2019
1		96 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 final	part355	09/25/2019

Labeler - Nutrix International,LLC (117341868)

Establishment
Name	Address	ID/FEI	Business Operations
Nutrix, LLC		079833114	manufacture(73333-096)