REBIRTH HAIR TONIC - witch hazel solution 
ZION SYNTHETIC FIBER CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient: WITCH HAZEL 0.1%

Inactive ingredients:
Water, Niacinamide, Panthenol, Dipotassium Glycyrrhizate, Menthol, Pyrrolidinyl Diaminopyrimidine Oxide, Salicylic Acid, Alcohol, Propylene Glycol, Butylene Glycol, Polygonum Multiflorum Root Extract, Portulaca Oleracea Extract, Oryza Sativa (Rice) Extract, Camellia Japonica Flower Extract, Sesamum Indicum (Sesame) Seed Extract, Glycine Max (Soybean) Seed Extract, Morus Alba Bark Extract, Artemisia Vulgaris Extract, Copper Tripeptide-1, PEG-60 Hydrogenated Castor Oil, Phenoxyethanol, Methyl Paraben, Hematite Extract, Aluminum Silicate, Topaz, Zeolite, Tourmaline, Triethanolamine, Disodium EDTA, Flavor

Purpose:
It appears to help to recover the hair damaged.
It appears to make a glossy and elastic hair by preventing the rough and dryness.

Warnings:
In case of having following symptoms after using this, you're advised to stop using it immediately.  If you keep using it,  the  symptoms will get worse and need to consult a dermatologist.
- In case of having problems such as red rash, swollenness, itching, stimulation during usage.
- In case of having the same symptoms above on the part you put this product on by direct sunlight.
You are banned to use it on the part where you have a scar, eczema, or dermatitis.
In case of getting it into your eyes, you have to wash it immediately.

Keep out of reach of children:
Keep out of the reach of babies and children.

Indication and usage:
Tighten the lid after using it.
Don't keep it in the place where the temperature is extremely hot or low and exposed the direct sunlight.    
Use it after Rebirth Hair Shampoo.

Dosage and administration:
Pumping it 2-3 drops on scalp of wet hair after shampoo, and massage gently until completely absorbed.

Image of carton

REBIRTH HAIR TONIC 
witch hazel solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44781-190
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.13 mL  in 130 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44781-190-01130 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/01/2010
Labeler - ZION SYNTHETIC FIBER CO., LTD. (688011147)
Registrant - ZION SYNTHETIC FIBER CO., LTD. (688011147)
Establishment
NameAddressID/FEIBusiness Operations
ZION SYNTHETIC FIBER CO., LTD.688011147manufacture

Revised: 9/2011
Document Id: e2761238-41a4-4e30-b274-557539924c20
Set id: 1213e3c7-b611-41a8-8d90-3d0529b39e7e
Version: 2
Effective Time: 20110918
 
ZION SYNTHETIC FIBER CO., LTD.