Indications and 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
Therabreath™ Healthy Gums Dentist Formulated Toothpaste, Clean Mint
- Manufacturer
- Church & Dwight Co., Inc.
- Effective date
- 2026-09-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- daily-update
- Hydrated at
- 2026-10-03 00:01:37
Label at a glance#
ProductTherabreath Healthy Gums
Active ingredientSTANNOUS FLUORIDE
Label structure9 sections
Dosage and administration
• 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
Contacts and useful links#
Websitewww.therabreath.com
WWW.THERABREATH.COM
WWW.THERABREATH.COMLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredient
Stannous fluoride 0.454% (0.14% w/v fluoride ion)
Purpose
Anticavity/Antigingivitis
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
WARNINGS SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
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 |
Inactive Ingredients
water, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, silica, sodium lauryl sulfate, flavor, sodium lauroyl sarcosinate, polyvinylpyrrolidone, titanium dioxide, xanthan gum, sucralose
Questions or Comments?
Therabreath is manufactured by
Church & Dwight Co., Inc., Ewing, NJ 08628 U.S.A
Phone: 1-800-973-7374 WEB: WWW.THERABREATH.COM
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LONG LASTING FOR EPIC FRESHNESS
TheraBreath™
HEALTHY GUMS
DENTIST FORMULATED TOOTHPASTE
Anticavity/Antigingivitis
REDUCES GUMLINE PLAQUE FOR 24 HOURS*
TWIN PACK *in a clinical study with twice daily brushing vs a regular toothpaste
Neutralizes the source of bad breath t
tin laboratory tests
Gently whitens
Dr. Harold Katz
Clean Mint
2 TUBES of 4.0 oz (113 g)
TOTAL NET WT. 8.0 oz (226 g)
Products#
Every source-derived product name is available through these pages.
- Therabreath Healthy Gums
- Stannous Fluoride
- FLUORIDE ION
- PEG-8
- SODIUM LAUROYL SARCOSINATE
- SILICON DIOXIDE
- TITANIUM DIOXIDE
- PENTASODIUM TRIPHOSPHATE
- HYDRATED SILICA
- XANTHAN GUM
- SODIUM LAURYL SULFATE
- CROSPOVIDONE, UNSPECIFIED
- WATER
- GLYCERIN
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10237-271 | 10237-271-24, 10237-271-07, 10237-271-04, 10237-271-22 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STANNOUS FLUORIDE | 3FTR44B32Q | ACTIM |
| PEG-8 | B697894SGQ | IACT |
| SODIUM LAUROYL SARCOSINATE | 632GS99618 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| PENTASODIUM TRIPHOSPHATE | 9SW4PFD2FZ | IACT |
| HYDRATED SILICA | Y6O7T4G8P9 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| CROSPOVIDONE, UNSPECIFIED | 2S7830E561 | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2025-08-01 | full-release | 2026-06-01 01:11:44 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 3c3683f0-8048-a648-e063-6394a90a258f | 3c3683f0-8047-a648-e063-6394a90a258f | 2025-08-01 | Warnings | 3c3683f0-8047-a648-e063-6394a90a258f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.