Label: IZUN PERIACTIVE MOUTHWASH- sambucus nigra flower extract, centella asiatica leaf extract, echinacea purpurea extract mouthwash
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Contains inactivated NDC Code(s)
NDC Code(s): 49589-112-01, 49589-112-02 - Packager: Izun Pharmaceuticals Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated January 31, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
Adults and children 12 years and older rinse for 60 seconds with 15 ml (3 teaspoonful twice a day) children 6-12 years rinse for 60 seconds with 10 ml (2 teaspoonful twice a day) children under 6 years of age do not use - do not eat, drink or rinse your mouth for 30 minutes after use
- do not swallow
- children 6 years to under 12 years of age: supervise use
- INDICATIONS & USAGE
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WARNINGS
Allergy Alert
Do not use if allergic to any of the ingredients. Stop use and ask a dentist if:
- gingivitis, bleeding, or redness persists for more than 2 weeks
- you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be the signs of periodontitis, a serious form of gum disease
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IZUN PERIACTIVE MOUTHWASH
sambucus nigra flower extract, centella asiatica leaf extract, echinacea purpurea extract mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49589-112 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CENTELLA ASIATICA LEAF (UNII: 6810070TYD) (CENTELLA ASIATICA LEAF - UNII:6810070TYD) CENTELLA ASIATICA LEAF 4 [hp_X] in 1 mL ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 4 [hp_X] in 1 mL SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) SAMBUCUS NIGRA FLOWER 3 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) LACTIC ACID (UNII: 33X04XA5AT) BRILLIANT BLUE G (UNII: M1ZRX790SI) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCRALOSE (UNII: 96K6UQ3ZD4) EDETATE DISODIUM (UNII: 7FLD91C86K) Product Characteristics Color blue Score Shape Size Flavor WINTERGREEN Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49589-112-01 500 mL in 1 TUBE; Type 0: Not a Combination Product 08/24/2018 2 NDC:49589-112-02 75 mL in 1 TUBE; Type 0: Not a Combination Product 08/24/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/24/2018 Labeler - Izun Pharmaceuticals Corporation (624194523) Establishment Name Address ID/FEI Business Operations Incos Cosmeceutica Industriale Srl 434933032 manufacture(49589-112)
