Purpose
Teeth cleaning
4-in-1 Teeth Care Pens Gel, Dentifrice
FDA Label NDC 83778-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Dentalbright Technology Co., Ltd for the product 4-in-1 Teeth Care Pens (NDC 83778-011). 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 purpose, active ingredient, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium Fluoride
Sodium Gluconate
Use
Those who want to clean and whiten their teeth.
Warnings
Product is not intended for use by children. Do not swallow. Do not use in eye area.
Do Not Use
Product is not intended for use by children.
When Using
Do not swallow. Do not use in eye area.
Stop Use
If there is any discomfort, please stop using.
Ask Doctor
If there is any discomfort, please consult a dentist immediately
Keep Oot Of Reach Of Children
keep out of reach of young children
Directions
1. Apply 2 pumps to a soft bristle toothbrush.
2. Gently brush it a circular motion for 2 minutes.
3. Expel excess and rinse mouth after use, do not swallow.
Other Information
please keep in dry and cool place
Inactive Ingredients
Aqua/Water、Sorbitol、Hydrated Silica、Xylitol、Glycerin、Aroma(Flavour)、Disodium Phosphate、Sodium Lauroyl Sarcosinate、Calcium Glycerophosphate、Cellulose Gum、Xanthan Gum、Tetrapotassium Pyrophosphate、Benzyl Alcohol、Caprylyl Glycol、Sucralose、Menthol、Pentylene Glycol、Zinc Lactate、Methyl Diisopropyl Propionamide、Benzoic Acid.
* Please review the disclaimer below.
