ROOTA RE V FOR WOMEN- panthenol shampoo

Roota Re V for women by

Drug Labeling and Warnings

Roota Re V for women by is a Otc medication manufactured, distributed, or labeled by Raphabio Inc, Grace C&T. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

panthenol

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

hair care

KEEP OUT OF REACH OF CHILDREN

keep out or reach of the children

INDICATIONS & USAGE

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

WARNINGS

stop use if irritation occurs

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROOTA RE V FOR WOMEN 
panthenol shampoo

Product 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)