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Drug Facts
Therabreath Paste, Dentifrice
FDA Label NDC 10237-271
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Therabreath (NDC 10237-271). 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 other, active ingredient, purpose, uses, warnings, stop use and ask a dentist if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
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)
* Please review the disclaimer below.
