Dr Dental Care 80ml
FDA Label NDC 69255-030

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jangin Pharm Co., Ltd. for the product Dr Dental Care 80ml (NDC 69255-030). 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, warnings, keep out of reach of children, use, directions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Active ingredient:
Sodium fluoride 0.02% (0.009% w/v fluoride ion)

Inactive Ingredient

Inactive ingredients:
Water, Alcohol (3%), Xylitol, Glycerin, Allantoin, Citric Acid, Sodium Citrate, Catechins, Sodium Benzoate, Menthol, Red Ginseng, Sophora Angustifolia Root, Swertia, Licorice, Caramel

Purpose

Purpose: Anticavity

Warnings

Warning:
1. Keep out of reach of children under 6 years old.
2. Avoid direct sunlight, store in room temperature.
3. Close lid after use.
4. Consult doctor before use if you are allergic to any of the ingredients.
5. If significant amount is accidentally swallowed, drink large amount of milk and get medical help.

Keep Out Of Reach Of Children

Keep out of reach of children:
If significant amount is accidentally swallowed, drink large amount of milk and get medical help.

Use

Use:
Mouthwash with outstanding oral disease prevention effect

Directions

Directions:
Rinse mouth with 10-15ml for 30 seconds.

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