DR. 9020 DENTAL CLINIC- sodium fluoride liquid 
JANGIN PHARM CO.,LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient : Sodium fluoride

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

prevent cavities, and remove bad breath

Keep out of reach of children

● 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.

● 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.

For dental use only

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DR. 9020 DENTAL CLINIC 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69255-200
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69255-200-01260 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/01/2018
Labeler - JANGIN PHARM CO.,LTD. (688733680)
Registrant - JANGIN PHARM CO.,LTD. (688733680)
Establishment
NameAddressID/FEIBusiness Operations
JANGIN PHARM CO.,LTD.688733680manufacture(69255-200)

Revised: 1/2019
Document Id: 7f10d5a6-2d5c-7ce2-e053-2991aa0ab425
Set id: 7f10d5a6-2d5b-7ce2-e053-2991aa0ab425
Version: 1
Effective Time: 20190109
 
JANGIN PHARM CO.,LTD.