Active Ingredients
Potassium nitrate 5%
Sodium Fluoride 0.15%
Teeth Desensitizing And Remineralizing Gel
FDA Label NDC 49410-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fuzhou Difeng Bio-tech Co., Ltd. for the product Teeth Desensitizing And Remineralizing Gel (NDC 49410-200). 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 ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredient, 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
Purpose
.antihypersensitivity
.anticavity
Uses
To relieve the discomfort from teeth sensitivity caused by thermal, chemical changes, periodontal
conditions...etc. Aids in the prevention of dental cavities.
Warnings
Do not swallow. Avoid contact with eyes. Discontinue use and consultant your dentist if allegric
reaction or gum irritation occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Adults and children 18 years of age and older: Directly apply 1ml-1.5ml of the product on
sensitive teeth, or use it in a custom mouth tray. Keep your mouth open for 10-15 mins. Then rinse
your month to clean the gel. Use it 1-2 times daily or as recommended by a dentist or physician.
Children under 18 years of age and pregnant, breast feeding women: consult a dentist or
physician prior to use.
Inactive Ingredient
Carbopol, Deionized Water, Glycerin, Menthol, Sodium Saccharine,SODIUM MONOFLUOROPHOSPHATE
Package Label.Principal Display Panel
1 (Label1)
* Please review the disclaimer below.
