Inactive Ingredients
Calcium Disodium EDTA, Flavor (Peppermint, Eucalyptus, Pink Grapefruit), Glycerin, PEG-40, Propylene Glycol, Water, Xylitol, Zinc Gluconate
Therastom Rinse
FDA Label NDC 70275-936
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Forward Science Technologies Llc for the product Therastom (NDC 70275-936). 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 inactive ingredients, active ingredient, purpose, use(s), warnings, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Cetylpyridinium Chloride 0.075%
Purpose
Antigingivitis/Antiplaque
Use(S)
• Helps control plaque that leads to bleeding gums.
• Helps prevent gingivitis, an early form of gum disease .
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 increased spacing between the teeth.
These may be signs or symptoms of periodontitis, a serious form of gum disease.
Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age.
If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Adults and children 12 years or older: Vigorously swish 20 ml (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
• Children 6 years to under 12 years of age: supervise use
• Children under 6 years of age: do not use
Other Information
This rinse is not intended to replace brushing or flossing
Dosage
Vigorously swish 20 ml (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out.
Package Label.Principal Display Panel
Therastombottlelabel (Tsbottle4)
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