Roota Re F Tonic: Package Insert and Label Information

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.

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

ROOTA RE F TONIC panthenol liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54576-3001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANTHENOL (PANTHENOL) PANTHENOL 0.5 mg in 100 mL

Inactive Ingredients Ingredient Name Strength 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 Code Package Description Multilevel Packaging 1 NDC:54576-3001-1 100 mL in 1 BOTTLE, WITH APPLICATOR None

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	Operations
Grace C&T		688222810	manufacture (54576-3001)

Revised: 12/2012 Raphabio Inc