Label: HANIP GARGLE APPLE FRAGRANCE- sodium fluoride mouthwash
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Contains inactivated NDC Code(s)
NDC Code(s): 59303-1001-1, 59303-1001-2, 59303-1001-3 - Packager: PISHONANC 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 July 13, 2013
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HANIP GARGLE APPLE FRAGRANCE
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59303-1001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 20 mg in 100000 mL Inactive Ingredients Ingredient Name Strength GREEN TEA LEAF (UNII: W2ZU1RY8B0) XYLITOL (UNII: VCQ006KQ1E) GRAPEFRUIT (UNII: O82C39RR8C) APPLE (UNII: B423VGH5S9) PEPPERMINT (UNII: V95R5KMY2B) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59303-1001-3 100 in 1 PACKAGE 1 NDC:59303-1001-2 3 in 1 PACKAGE 1 NDC:59303-1001-1 12 mL in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 07/13/2013 Labeler - PISHONANC Co, Ltd (557787661) Registrant - PISHONANC Co, Ltd (557787661) Establishment Name Address ID/FEI Business Operations PISHONANC Co, Ltd 557787661 manufacture(59303-1001)