Label: ROOTA RE V TONIC- panthenol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 54576-4001-1 - Packager: Raphabio Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated December 31, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Aqua (Water), rosa centifolia flower water, sd alcohol 40, butylene glycol, peg-40 hydrogenated castor oil, polysorbate 80, urea, menthol, salicylic acid, methylparaben, , dipotassium glycyrrhizate, hydrolyzed soybean protein, carmellia sinensis leaf extract, , allantoin, sodium citrate, zinc sulfate, disodium edta, rosemary leaf oil, niacinamide, panax ginseng root extract, pyridoxine hci, sophora angustifolia root extract, acorus calamus root extract, polygonum multiflorum root extract, morus alba bark extract, licorice root extract, ginkgo biloba leaf, ficus carica fruit extract, morus alba fruit extract, fragrance
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROOTA RE V TONIC
panthenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54576-4001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL 0.5 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) POLYSORBATE 80 (UNII: 6OZP39ZG8H) UREA (UNII: 8W8T17847W) MENTHOL (UNII: L7T10EIP3A) SALICYLIC ACID (UNII: O414PZ4LPZ) ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SOY PROTEIN (UNII: R44IWB3RN5) ALLANTOIN (UNII: 344S277G0Z) SODIUM CITRATE (UNII: 1Q73Q2JULR) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) EDETATE DISODIUM (UNII: 7FLD91C86K) FICUS CARICA WHOLE (UNII: MAW09HMQ3X) NIACINAMIDE (UNII: 25X51I8RD4) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F) GINKGO (UNII: 19FUJ2C58T) MORUS ALBA BARK (UNII: 7O71A48NDP) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54576-4001-1 100 mL in 1 BOTTLE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/31/2012 Labeler - Raphabio Inc (688480119) Registrant - Raphabio Inc (688480119) Establishment Name Address ID/FEI Business Operations Grace C&T 688222810 manufacture(54576-4001)