REBIRTH HAIR- pyrithione zinc shampoo

REBIRTH HAIR by

Drug Labeling and Warnings

REBIRTH HAIR 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: PYRITHIONE ZINC

INACTIVE INGREDIENT

Inactive ingredients:

Water, Ammonium Laureth Sulfate, Potassium Cocoyl Glycinate, Cocamidopropyl Betaine, Lauramide DEA, Portulaca Oleracea Extract, Propylene Glycol, Copper Tripeptide-1, Panthenol, Diglycerin,  Polyquaternium-10, Pyrrolidinyl Diaminopy-rimidine Oxide, Salicylic Acid, Flavor, Polyquaternium-7, Artemisia Vulgaris Extract, Glycine Soja (Soybean) Extract, Sesamum Indicum (Sesame) Seed Extract,
Oryza Sativa (Bran) Rice Extract, Camellia Japonica Flower Extract, Morus Alba Root Extract, Polygonum Multiflorum Root Extract, Citric Acid, Hematite Extract, Aluminum Silicate, Topaz, Zeolite,  Tourmaline, Tetrasodium EDTA, Disodium EDTA, Methylchloroisothiazolinone Methylisothiazolinone

PURPOSE

Purpose:

Effects for the damaged hair
Removes dandruff, antifungal, itching, and waste matter on the scalp

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.    
Massage the scalp while washing hair and rinse out fully.
Wash your hair for about 2 minutes.
Please shampoo everyday or every other day.

DOSAGE & ADMINISTRATION

Dosage and administration:
Take up about one quarter dollar coin of it and put it on palms, and rub it having enough foam and shampoo.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REBIRTH HAIR 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44781-180
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE - UNII:6GK82EC25D)	PYRITHIONE ZINC	0.6 mL  in 360 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
PURSLANE (UNII: M6S840WXG5)
Propylene Glycol (UNII: 6DC9Q167V3)
PANTHENOL (UNII: WV9CM0O67Z)
DIGLYCERIN (UNII: 3YC120743U)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
SALICYLIC ACID (UNII: O414PZ4LPZ)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D)
SESAME OIL (UNII: QX10HYY4QV)
CAMELLIA JAPONICA FLOWER (UNII: KUB8101TNF)
MORUS ALBA ROOT (UNII: CST1G9BZGD)
FALLOPIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALUMINUM SILICATE (UNII: T1FAD4SS2M)
EDETATE SODIUM (UNII: MP1J8420LU)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44781-180-01	360 mL in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	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