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 Type HUMAN OTC DRUG Item Code (Source) NDC:54576-4001
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL 0.5 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
UREA (UNII: 8W8T17847W)  
MENTHOL (UNII: L7T10EIP3A)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SOY PROTEIN (UNII: R44IWB3RN5)  
ALLANTOIN (UNII: 344S277G0Z)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FICUS CARICA WHOLE (UNII: MAW09HMQ3X)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)  
GINKGO (UNII: 19FUJ2C58T)  
MORUS ALBA BARK (UNII: 7O71A48NDP)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54576-4001-1 100 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(54576-4001)

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