![IZUN PERIACTIVE MOUTHWASH (SAMBUCUS NIGRA FLOWER EXTRACT, CENTELLA ASIATICA LEAF EXTRACT, ECHINACEA PURPUREA EXTRACT) MOUTHWASH [IZUN PHARMACEUTICALS CORPORATION]](https://medic.hrt.org//dailymed/images/7430cde1-3302-080a-e053-2991aa0adc84/Pages from PeriActive FDA registration (includes label)_Page_1.jpg)
![IZUN PERIACTIVE MOUTHWASH (SAMBUCUS NIGRA FLOWER EXTRACT, CENTELLA ASIATICA LEAF EXTRACT, ECHINACEA PURPUREA EXTRACT) MOUTHWASH [IZUN PHARMACEUTICALS CORPORATION]](https://medic.hrt.org//dailymed/images/7430cde1-3302-080a-e053-2991aa0adc84/Pages from PeriActive FDA registration (includes label)_Page_2.jpg)
| NDC | 49589-112-01, 49589-112-02 |
| Set ID | 7430cde1-3302-080a-e053-2991aa0adc84 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Izun Pharmaceuticals Corporation |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- 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
-
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)
