ROOTA RE F TONIC  - panthenol liquid 
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), sd alcohol 40, butylene glycol, peg-40 hydrogenated castor oil, polysorbate 80, urea, menthol, salicylic acid, glycolic acid, dipotassium glycyrrhizate, camphor, tocopheryl acetate, peppermint oil, 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 extract, copper tripeptide-1

hair care

keep out of reach of the children

after shampooing, dry your hair and sclap thoroughly
apply the tonic into scalp and gently massage with fingertips to help absorption

stop use if irritation occurs


for external use only

package label
ROOTA RE F TONIC  
panthenol liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54576-3001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PANTHENOL (PANTHENOL) PANTHENOL0.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
BUTYLENE GLYCOL 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
POLYSORBATE 80 
UREA 
MENTHOL 
SALICYLIC ACID 
GLYCOLIC ACID 
GLYCYRRHIZINATE DIPOTASSIUM 
CAMPHOR (NATURAL) 
.ALPHA.-TOCOPHEROL ACETATE 
MENTHA PIPERITA 
ALLANTOIN 
SODIUM CITRATE 
ZINC SULFATE 
EDETATE DISODIUM 
ROSEMARY 
NIACINAMIDE 
ASIAN GINSENG 
PYRIDOXINE HYDROCHLORIDE 
SOPHORA FLAVESCENS ROOT 
ACORUS CALAMUS ROOT 
FALLOPIA MULTIFLORA ROOT 
MORUS ALBA BARK 
GLYCYRRHIZA GLABRA 
GINKGO 
PREZATIDE COPPER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54576-3001-1100 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(54576-3001)

Revised: 12/2012
Document Id: 8262bbb8-27c7-4ee5-ab48-289af41da4a0
Set id: 3e00b36f-fe7b-4a17-98aa-6a53b1fadc7c
Version: 1
Effective Time: 20121231
 
Raphabio Inc