Label: DR DENTAL CARE 80ML- sodium fluoride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 69255-030-01 - Packager: Jangin Pharm Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 September 29, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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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
- Use
- Directions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR DENTAL CARE 80ML
sodium fluoride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69255-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.016 mg in 80 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69255-030-01 80 mL in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 08/01/2014 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(69255-030)