Label: ROOTA RE V FOR WOMEN- panthenol shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 54576-2001-1 - Packager: Raphabio Inc
- 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 December 31, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Aqua (Water), Cocamide DEA, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betain, Glycerin, Tetrasodium EDTA, Zinc Pyrithion, Sodium Chloride, Sodium laureth sulfate, Glyceryl Distearate, Menthol,Polyquarternium-10, Mentha Piperita (Peppermint) oil, Salicylic Acid,Cetyl Alcohol, Allantoin,Citric Acid,Zinc Sulfate,Disodium EDTA,Rosmarinus Officinalis (Rosemary) Leaf Oil, Pyridoxine HCl,Sophora Angustifolia Root Extract,Acorus Calamus Root Extract ,Polygonum Multiflorum Root Extract, Morus Alba Bark Extract, Glycyrrhiza Glabra (Licorice) Root Extract ,Ginkgo Biloba Leaf Extract, Urea,Niacinamide,Sodium Hydroxide,Copper Tripeptide-1,Methylchloroisothiazolinone, Methylisothiazolinone, cocamide DEA, Rosa centifolia flower water, sophora angustifolia root extract, polygonum multiflorum root extract, rosa canina fruit oil, hydrolyzed soybean protein, ficus carica 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 FOR WOMEN
panthenol shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54576-2001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL 1.2 mg in 240 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCO DIETHANOLAMIDE (UNII: 92005F972D) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLYCERIN (UNII: PDC6A3C0OX) EDETATE SODIUM (UNII: MP1J8420LU) PYRITHIONE ZINC (UNII: R953O2RHZ5) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) GLYCERYL DISTEARATE (UNII: 73071MW2KM) MENTHOL (UNII: L7T10EIP3A) ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY) SALICYLIC ACID (UNII: O414PZ4LPZ) CETYL ALCOHOL (UNII: 936JST6JCN) ALLANTOIN (UNII: 344S277G0Z) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) EDETATE DISODIUM (UNII: 7FLD91C86K) FALLOPIA MULTIFLORA ROOT (UNII: AUZ3VD75MC) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) SOY PROTEIN (UNII: R44IWB3RN5) ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F) FIG (UNII: TGD87RII2U) MORUS ALBA BARK (UNII: 7O71A48NDP) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) GINKGO (UNII: 19FUJ2C58T) UREA (UNII: 8W8T17847W) NIACINAMIDE (UNII: 25X51I8RD4) SODIUM HYDROXIDE (UNII: 55X04QC32I) CLOVE (UNII: K48IKT5321) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54576-2001-1 240 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(54576-2001)
