Active Ingredient
sodium fluoride
T-series
FDA Label NDC 76058-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sungwon Pharmaceutical Co., Ltd. for the product T-series (NDC 76058-001). 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 active ingredient, inactive ingredient, purpose, keep out of reach of children, warning, uses, indication & usage section, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
silica, sodium pyrophosphate, pyridoxine hydrochloride, D-sorbitol, microcrystalline cellulose, xylitol, sodium bicarbonate, tea extract, tocopherol acetate, etc
Purpose
■ Keeps teeth white and strong
■ Keep the oral cavity clean
■ Prevents tooth decay and bad breath caused by fluoride
■ Removing plaque, preventing gingivitis and periodontitis
■ Periodontal Disease Prevention
■ Gum Disease Prevention
■ Prevention of tartar deposition
Keep Out Of Reach Of Children
Keep out of reach of children.
Warning
For oral use only
When using this product
■ This toothpaste has a 1,000 ppm fluoride content
■ Do not use other than brushing teeth and be careful not to swallow
Keep out of reach of children
■ if swallowed, get medical help or contact a person control center immediately
Uses
for oral use only
Indication & Usage Section
■ Within 3 times a day, chew 1 or 2 tablets sufficiently and then brush your teeth by brushing or brush your teeth by brushing them
■ scrub softly as like doing massage
Package Label.Principal Display Panel
Label (Label)
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