LINHART

Manufacturer
Nutrix International,LLC | Nutrix, LLC
Effective date
2020-01-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:56

Label at a glance#

ProductLINHART
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Indications and uses

Aids in the prevention of dental decay.

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.25%

Purpose

OTC - PURPOSE SECTION

Anticavity

Indications and Usage

INDICATIONS & USAGE SECTION

Aids in the prevention of dental decay.

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

(212) 599-2397

Primary Packaging Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube ArtworkTube Artwork

Packaging Label - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ArtworkCarton Artwork

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1044547sodium fluoride 0.25 % ToothpastePSN2
1044547sodium fluoride 0.0025 MG/MG ToothpasteSCD2
1044547sodium fluoride 0.25 % (fluoride ion 0.15 % ) ToothpasteSY2
1044547sodium fluoride 0.25 % ToothpasteSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73333-096-022022-01-28C16284748780-1d6a99b39-ecdf-a426-e053-dadaa90af4c29c48b561-7848-3e88-e053-2a95a90a5675

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73333-096-02LINHART96 g in 1 TUBEPASTE, DENTIFRICE962
73333-096-02LINHART1 in 1 CARTONPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73333-096LINHART (SODIUM FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [NUTRIX INTERNATIONAL,LLC]2Legacy NDC, 2 package rows20200117_9c48b561-7848-3e88-e053-2a95a90a5675.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73333-09673333-096-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9c48a724-8015-2470-e053-2995a90a63659c48b561-7848-3e88-e053-2a95a90a56752020-01-16WarningsExact identifier
spl id: 9c48a724-8015-2470-e053-2995a90a6365
spl set id: 9c48b561-7848-3e88-e053-2a95a90a5675

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.