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Drug Facts
Therabreath Paste, Dentifrice
FDA Label NDC 10237-272
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 10237-272). 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, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium fluoride 0.24% (0.17% w/v fluoride ion)
Purpose
Anticavity
Use
aids in the prevention of dental decay
Warnings
Warning
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, sodium bicarbonate, sorbitol, hydrated silica, glycerin, tetrasodium pyrophosphate, sodium tripolyphosphate, flavor, sodium lauryI sulfate, sodium lauroyl sarcosinate, poloxamer 407, xanthan gum, titanium dioxide, sodium saccharin, 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
Prinicpal Display Panel
LONG LASTING FOR EPIC FRESHNESS
TheraBreath ™
WHITENING
DENTIST FORMULATED TOOTHPASTE
Anticavity
SIGNIFICANTLY WHITENS AFTER 1 WEEK*
TWIN PACK *with twice daily brushing
Neutralizes the source of bad breath t
tin laboratory tests
Gently whitens
Dr. Harold Katz
Dazzling Mint
2 TUBES of 4.0 oz (113 g)
TOTAL NET WT. 8.0 oz (226 g)
* Please review the disclaimer below.
