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Drug Facts
Therabreath Paste, Dentifrice
FDA Label NDC 10237-273
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 10237-273). 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 ingredients, purpose, uses, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Potassium nitrate 5.0%
Sodium fluoride 0.24% (0.16% w/v fluoride ion)
Purpose
Potassium nitrate - Tooth desensitizer
Sodium fluoride - Anticavity
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
Warnings
Warnings
Otc - Do Not Use
Do not use longer than 4 weeks unless recommended by a dentist or doctor
Otc - Stop Use
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.
Otc - Keep Out Of Reach Of Children
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.
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
Inactive Ingredients
water, sodium bicarbonate, sorbitol, hydrated silica, glycerin, sodium methyl cocoyl taurate, flavor, poloxamer 407, sodium saccharin, xanthan gum, titanium dioxide, sucralose
Otc - Questions
Phone: 1-800-973-7374
WEB: WWW.THERABREATH.COM
Package Label.Principal Display Panel
TheraBreath TM
SENSITIVE
DENTIST FORMULATED
TOOTHPASTE
Anticavity for Senstive Teeth
PROVIDES 24/7
SENSITIVITY RELIEF*
*with twice daily brushing
Neutralizes the source of bad breath t
tin laboratory tests
Gently whitens
GENTLE MINT
NET WT. 4.0 oz (113g)
* Please review the disclaimer below.
