LINHART- sodium fluoride toothpaste paste, dentifrice

Linhart by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Fact 

Active ingredient

Sodium Fluoride 0.25%

Purpose 

Anticavity

Uses

Aids in the prevention of tooth 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 the 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.
• Chlidren 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 Barbadenias Leaf Juice, Allantoin, Sodium Saccharin, Theobromine, Bisabolol

Principal Primary Panel - Carton 3.5oz

LINHART with Linamel

Fluoride Toothpaste

NET WT 3.5oz(99g)

Principal Primary Panel - Tube 3.5oz

LINHART with Linamel

Fluoride Toothpaste

NET WT 3.5oz (99g)

INGREDIENTS AND APPEARANCE

LINHART 
sodium fluoride toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70926-100
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)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALLANTOIN (UNII: 344S277G0Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
THEOBROMINE (UNII: OBD445WZ5P)

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: 70926-100-64	1 in 1 CARTON	08/17/2017
1		99 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	08/17/2017

Labeler - Linhart Inc (080343587)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(70926-100)