ROOTA RE V FOR WOMEN - panthenol shampoo 
Raphabio Inc

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.

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Drug Facts

panthenol

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

hair care

keep out or reach of the children

1. apply sufficient quantity to intended part
2. scrub softly as like doing massage

stop use if irritation occurs


for external use only

package label
ROOTA RE V FOR WOMEN 
panthenol shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54576-2001
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 12/2012
Document Id: 63abf12b-aa96-4128-9098-5485a3f03532
Set id: 226bef7a-74e2-4bc8-a31a-d558bedd5dca
Version: 1
Effective Time: 20121231
 
Raphabio Inc