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STANNOUS FLUORIDE
Massco Dental A Division of Dunagin Pharmaceuticals · ORAL

Product NDC: 63783-005, 63783-006, 63783-008, 63783-009, 63783-015

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameSTANNOUS FLUORIDE
Labeler / manufacturerMassco Dental A Division of Dunagin Pharmaceuticals
RouteORAL
Drug classDrug class not supplied in source label
Product NDC63783-005, 63783-006, 63783-008, 63783-009, 63783-015
Label effective date2025-12-11

Official product label reference

Kids Choice — Massco Dental A Division of Dunagin Pharmaceuticals

This page contains 8 source sections for STANNOUS FLUORIDE, oral route. Label set cbf7907e-72c7-4328-8bd4-bf70daa35ef9, version 12.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

USE Aids in the prevention of dental decay.
Warnings
WARNINGS If more than amount used for brushing is accidentally swallowed, seek medical help from a poison control center.
Active ingredient
ACTIVE INGREDIENT Active Ingredient: Stannous Fluoride
Inactive ingredient
INACTIVE INGREDIENTS Glycerine, Hydroxy Ethyl Celluulose, Xylitol
Child safety
KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN
While using this medicine
DIRECTIONS FOR USE Adults and Children 12 years and Older: Use after regular brushing and flossing. Place gel across length of toothbrush. Brush Thoroughly. Keep on teeth for 1 - 1 1/2 minutes and then expectorate (spit out). Do not swallow. Use once a day for cavity prevention. Supervise children until capable of using without supervision. Children 6-11 Years: See directions above. Adult supervision required. Children Under 6: Consult a Dentist or Physician.
General precautions
OTHER INFORMATION This is a fluoride prevention treatment gel, not a toothpaste. Read directions carefully before use. This product may produce surface discoloration of the teeth. Adequate toothbrushing may prevent discoloration. Discoloration is not harmful or permanent and may be removed by a dental professional. Do not freeze or expose to extreme heat.
Questions
QUESTIONS ? COMMENTS ? Questions?? Comments?? Call 1-479-787-5168 M-F 9am to 5pm CST

Official sources and product identifiers

Substances listed: STANNOUS FLUORIDE

RxNorm identifiers: 237847, 1037034

Package NDC codes

63783-005-04, 63783-006-04, 63783-008-04, 63783-009-04, 63783-015-04

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.