ROOTA RE F TONIC- panthenol liquid

Roota Re F Tonic by

Drug Labeling and Warnings

Roota Re F Tonic by is a Otc medication manufactured, distributed, or labeled by Raphabio Inc, Grace C&T. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

panthenol

INACTIVE INGREDIENT

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

PURPOSE

hair care

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

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

WARNINGS

stop use if irritation occurs

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROOTA RE F TONIC  
panthenol liquid

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

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)
GLYCOLIC ACID (UNII: 0WT12SX38S)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ZINC SULFATE (UNII: 89DS0H96TB)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ROSEMARY (UNII: IJ67X351P9)
NIACINAMIDE (UNII: 25X51I8RD4)
ASIAN GINSENG (UNII: CUQ3A77YXI)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)
FALLOPIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)
MORUS ALBA BARK (UNII: 7O71A48NDP)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
GINKGO (UNII: 19FUJ2C58T)
PREZATIDE COPPER (UNII: 6BJQ43T1I9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54576-3001-1	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(54576-3001)