Official product label reference

TheraBreath — Church & Dwight Co., Inc.

This page contains 11 source sections for POTASSIUM NITRATE, SODIUM FLUORIDE, dental route. Label set 4b812a38-f7cb-51c8-e063-6394a90ab82c, version 2.

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

Uses • aids in the prevention of dental decay • helps reduce and builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

Purpose

Purpose Potassium nitrate - Tooth desensitizer Sodium fluoride - Anticavity

Dosage and administration — label text

Directions • do not swallow • supervise children as necessary until capable of using without supervision adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. children under 12 years of age: consult a dentist or doctor

Warnings

Warnings Do not use longer than 4 weeks unless recommended by a dentist or doctor Stop use and ask a dentist or doctor if sensitivity persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Unclassified section

Drug Facts

Active ingredient

Active ingredients Potassium nitrate 5.0% Sodium fluoride 0.24% (0.16% w/v fluoride ion)

Do not use

Do not use longer than 4 weeks unless recommended by a dentist or doctor

When to stop use and seek help

Stop use and ask a dentist or doctor if sensitivity persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Child safety

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Inactive ingredient

Inactive ingredients water, sodium bicarbonate, sorbitol, hydrated silica, glycerin, sodium methyl cocoyl taurate, flavor, poloxamer 407, sodium saccharin, xanthan gum, titanium dioxide, sucralose

Questions

Phone: 1-800-973-7374 WEB: WWW.THERABREATH.COM

Official sources and product identifiers

DailyMed — complete source labelVerify the current version and original formatting, including tables and diagrams.
openFDA — structured source recordMachine-readable label source, linked by the exact label set ID.

Substances listed: SODIUM FLUORIDE, POTASSIUM NITRATE

RxNorm identifiers: 1038929

Package NDC codes

10237-273-04, 10237-273-24, 10237-273-07

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.

TheraBreath drug information