Label: DR. 9020 DENTAL CLINIC- sodium fluoride liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 69255-200-01 - Packager: JANGIN PHARM CO.,LTD.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 9, 2019
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
-
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
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DR. 9020 DENTAL CLINIC
sodium fluoride liquidProduct 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)
