Sodium Fluoride Cream
FDA Label NDC 65517-2000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dukal Llc for the product Sodium Fluoride (NDC 65517-2000). 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, use, warnings section, keep out of reach of children, directions, inactive ingredients, expiration date, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium fluoride 0.22%

Purpose

Anticavity 

Use

aids in the prevention of dental cavities  

Warnings Section

Warnings

Keep Out Of Reach Of Children

Keep out of reach of children under six years of age. If you accidently swallow more than used for brushing seek professional assistance or contact a Poison Control Center immediately

Directions

Adults and children 2 years: and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.

Children under 6 years: To minimize swallowing use a pea sized amount and supervise brushing until good habits are established.

Children under 2 years: Ask a doctor or physician.

Inactive Ingredients

calcium carbonate,water,sorbitol, sodium lauryl sulfate, silica, carboxymethyl cellulose, flavor, potassium nitrate, sodium benzoate, sodium saccharin, menthol

Expiration Date

Expiration date & batch No. on crimp of tube

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