REBIRTH HAIR TONIC- witch hazel solution

REBIRTH HAIR TONIC by

Drug Labeling and Warnings

REBIRTH HAIR TONIC by is a Otc medication manufactured, distributed, or labeled by ZION SYNTHETIC FIBER CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient: WITCH HAZEL 0.1%

INACTIVE INGREDIENT

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

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

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

INDICATIONS & USAGE

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 & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	0.13 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
1	NDC: 44781-190-01	130 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