ROOTA RE V 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), rosa centifolia flower water, sd alcohol 40, butylene glycol, peg-40 hydrogenated castor oil, polysorbate 80, urea, menthol, salicylic acid, methylparaben, , dipotassium glycyrrhizate, hydrolyzed soybean protein, carmellia sinensis leaf extract, , 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, ficus carica fruit extract, morus alba fruit extract, fragrance

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 V TONIC 
panthenol liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54576-4001
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 
ROSA CENTIFOLIA FLOWER 
GLYCYRRHIZINATE DIPOTASSIUM 
METHYLPARABEN 
.ALPHA.-TOCOPHEROL ACETATE 
SOY PROTEIN 
ALLANTOIN 
SODIUM CITRATE 
ROSA CANINA FRUIT OIL 
EDETATE DISODIUM 
FICUS CARICA WHOLE 
NIACINAMIDE 
PYRIDOXINE HYDROCHLORIDE 
SOPHORA FLAVESCENS ROOT 
ACORUS CALAMUS ROOT 
GINKGO 
MORUS ALBA BARK 
GLYCYRRHIZA GLABRA 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54576-4001-1100 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(54576-4001)

Revised: 12/2012
Document Id: 85a5ce96-0229-4cff-928e-c422fbb37e0b
Set id: 30a75e94-3964-4a42-a6e3-0de6ab290ce5
Version: 1
Effective Time: 20121231
 
Raphabio Inc