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 / manufacturerChurch & Dwight Co., Inc.
RouteORAL
Drug classDrug class not supplied in source label
Product NDC10237-270
Label effective date2026-08-21
Official product label reference
Therabreath Deep Clean — Church & Dwight Co., Inc.
This page contains 10 source sections for STANNOUS FLUORIDE, oral route. Label set 3c372f26-e0c4-0659-e063-6294a90ae9f9, version 2.
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 prevent • gingivitis, an early form of gum disease • bleeding gums • helps interfere with harmful effects of plaque associated with gingivitis
Purpose
Purpose Anticavity/Antigingivitis
Dosage and administration — label text
Directions • do not swallow • supervise children as necessary until capable of using without supervision 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 children under 6 years of age instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years of age consult a dentist or doctor
Table text from source:
| 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
| children under 6 years of age | instruct in good brushing and rinsing habits (to minimize swallowing)
| children under 2 years of age | consult a dentist or doctor
Warnings
Warnings Stop use and ask a dentist if • gingivitis, bleeding, or redness persists for more than 2 weeks • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children under 6 years of age. 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 Ingredient Stannous fluoride 0.454% (0.14% w/v fluoride ion)
Do not use
Stop use and ask a dentist if • gingivitis, bleeding, or redness persists for more than 2 weeks • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Child safety
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Questions or Comments? Therabreath™ is manufactured by Church & Dwight Co., Inc., Ewing, NJ 02628 U.S.A. Phone: 1-800-973-7374 WEB: WWW.THERABREATH.COM
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.