Take Home Fluoride
FDA Label NDC 50227-1006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Patterson Dental Supply Inc for the product Take Home Fluoride (NDC 50227-1006). 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 indications, active ingredient, other ingredients, directions, warnings, precautions, other, principal display panel - 56 gm tube label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Indications

Helps prevent dental caries and hypersensitivity.

Active Ingredient

Sodium Fluoride 1.1% (0.5% Fluoride Ion)

Other Ingredients

Purified water, glycerin, Xylitol and other sweeteners. Contains FD&C Blue #1

Directions

Adults and children six years of age and older should brush with PATTERSON BRAND TAKE HOME FLUORIDE 1.1% NEUTRAL SODIUM FLUORIDE GEL, once at bedtime.

  • Apply thin bead of gel to toothbrush and brush for at least one minute making sure all tooth surfaces are covered.
  • Adults: expectorate thoroughly. Do not rinse, eat, or drink for at least 30 minutes after use.
    Children 6 and older: expectorate and rinse thoroughly. If recommended by your dental professional, this product can be used in place of your regular toothpaste.

Warnings

DO NOT SWALLOW. Supervision is required while children are using this product in order to avoid ingestion. Swallowing excessive amounts of fluoride could cause dental fluorosis. KEEP OUT OF REACH OF INFANTS & CHILDREN.

Precautions

For Professional Use only. Federal (USA) law prohibits dispensing without a prescription. Store at controlled room temperature 68° -77° F (20° - 25°C).

Other

NDC# 5022710062

Manufactured in the USA

Questions? Call your dentist for more information.

Distributed by
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
St. Paul, MN 55120

Reorder# 088-6093 12/Case

Principal Display Panel - 56 Gm Tube Label

PATTERSON BRAND

Take Home Fluoride
1.1% Neutral Sodium Fluoride Gel

Cool
Mint

Contains
Xylitol
Natural Sweetener

Net Wt. 2 Oz (56gm)

Principal Display Panel (Fluoride 01)

Principal Display Panel (Fluoride 01)

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