Linhart
FDA Label NDC 70926-100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Linhart Inc for the product Linhart (NDC 70926-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, directions, inactive ingredients, principal primary panel - carton 3.5oz, principal primary panel - tube 3.5oz, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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. 

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)

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