ROOTA RE F FOR MEN  - 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), Sodium Laureth Sulfate, Cocamide DEA, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betain, Glycerin, Tetrasodium EDTA, Zinc Pyrithion, Sodium Chloride, 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

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 F FOR MEN  
panthenol shampoo
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54576-1001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PANTHENOL (PANTHENOL) PANTHENOL1.2 mg  in 240 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
COCO DIETHANOLAMIDE 
SODIUM LAUROYL SARCOSINATE 
COCAMIDOPROPYL BETAINE 
GLYCERIN 
EDETATE SODIUM 
PYRITHIONE ZINC 
SODIUM CHLORIDE 
SODIUM LAURETH SULFATE 
GLYCERYL DISTEARATE 
MENTHOL 
PEPPERMINT 
SALICYLIC ACID 
CETYL ALCOHOL 
ALLANTOIN 
CITRIC ACID MONOHYDRATE 
ZINC SULFATE 
EDETATE DISODIUM 
ROSEMARY 
PYRIDOXINE HYDROCHLORIDE 
SOPHORA FLAVESCENS ROOT 
ACORUS CALAMUS ROOT 
FALLOPIA MULTIFLORA ROOT 
MORUS ALBA BARK 
GLYCYRRHIZA GLABRA 
GINKGO 
UREA 
NIACINAMIDE 
SODIUM HYDROXIDE 
PREZATIDE COPPER 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54576-1001-1240 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/31/2012
Labeler - Raphabio Inc (688480119)
Registrant - Raphabio Inc (688480119)
Establishment
NameAddressID/FEIBusiness Operations
Grace C&T688222810manufacture(54576-1001)

Revised: 12/2012
Document Id: e8fe11ac-688d-4443-bcfb-df8122a8d5f4
Set id: 889fb3cb-5a68-483b-aae7-e6e3957821eb
Version: 1
Effective Time: 20121231
 
Raphabio Inc