NDC Code(s) : 44781-190-01
Packager : ZION SYNTHETIC FIBER CO., LTD.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

REBIRTH HAIR TONIC WITCH HAZEL SOLUTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:44781-190
Route of Administration CUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WITCH HAZEL(UNII: 101I4J0U34)
(WITCH HAZEL - UNII:101I4J0U34) 		WITCH HAZEL0.13 mL in 130 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
NIACINAMIDE(UNII: 25X51I8RD4)
PANTHENOL(UNII: WV9CM0O67Z)
Menthol(UNII: L7T10EIP3A)
SALICYLIC ACID(UNII: O414PZ4LPZ)
ALCOHOL(UNII: 3K9958V90M)
Propylene Glycol(UNII: 6DC9Q167V3)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
FALLOPIA MULTIFLORA ROOT(UNII: AUZ3VD75MC)
PURSLANE(UNII: M6S840WXG5)
CAMELLIA JAPONICA FLOWER(UNII: KUB8101TNF)
SESAME OIL(UNII: QX10HYY4QV)
SOYBEAN(UNII: L7HT8F1ZOD)
MORUS ALBA POLLEN(UNII: 3I9T68187H)
ARTEMISIA VULGARIS POLLEN(UNII: ANT994T71D)
POLYOXYL 60 HYDROGENATED CASTOR OIL(UNII: 02NG325BQG)
Phenoxyethanol(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
TROLAMINE(UNII: 9O3K93S3TK)
EDETATE DISODIUM(UNII: 7FLD91C86K)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:44781-190-01130 mL in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 04/01/2010

LABELER - ZION SYNTHETIC FIBER CO., LTD.(688011147)

REGISTRANT - ZION SYNTHETIC FIBER CO., LTD.(688011147)

Establishment
Name Address ID/FEI Business Operations
ZION SYNTHETIC FIBER CO., LTD. 688011147 manufacture

PRINCIPAL DISPLAY PANEL

Image of carton