DR. 9020 DENTAL CLINIC- sodium fluoride liquid

Dr. 9020 Dental Clinic by

Drug Labeling and Warnings

Dr. 9020 Dental Clinic by is a Otc medication manufactured, distributed, or labeled by JANGIN PHARM CO.,LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient : Sodium fluoride

INACTIVE INGREDIENT

Preservatives-Sodium Benzoate

Other additives-L-Menthol, Sophora Angustifolia Root Extract, Glycyrrhiza Inflata Root Extract, Glycerin, Camellia Sinensis Catechins, Saccharin Sodium Hydrate, Sodium Citrate Hydrate, Citric Acid Hydrate, Xylitol, DI-Water, Caramel Colorant, Red Ginseng Extract, Polyoxyl 40 Hydrogenated Castor Oil

PURPOSE

prevent cavities, and remove bad breath

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

● Administration and doses : Once a day (mainly before bed), use it after brushing thoroughly. 6 years old to adults:10ml into your mouth, mix well for 1 minute, then spit. Be careful not to eat or drink food for 30 minutes after use to obtain sufficient effect.

WARNINGS

● Caution : 1) The fluoride content of this product is 90.5ppm. 2) Do not use this product - Anyone who is hypersensitive to this product. 3) Other Precautions when using this product-Do not swallow. Do not use for children under 6 years old unless instructed by a dentist. Keep out of reach of children. If they drink lots of medicine, feed large amounts of milk and follow doctor's instructions. 4) Storage precautions and other precautions when using this product-Keep out of the reach of children. Avoid direct sunlight. To shade the light, store in a cool place. To prevent misuse and preserve quality, do not change the container.

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR. 9020 DENTAL CLINIC 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69255-200
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
LEVOMENTHOL (UNII: BZ1R15MTK7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69255-200-01	260 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/01/2018

Labeler - JANGIN PHARM CO.,LTD. (688733680)

Registrant - JANGIN PHARM CO.,LTD. (688733680)

Establishment
Name	Address	ID/FEI	Business Operations
JANGIN PHARM CO.,LTD.		688733680	manufacture(69255-200)