REBIRTH HAIR - pyrithione zinc shampoo 
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: PYRITHIONE ZINC

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:

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

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

Image of carton

REBIRTH HAIR 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44781-180
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE - UNII:6GK82EC25D) PYRITHIONE ZINC0.6 mL  in 360 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44781-180-01360 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H04/01/2010
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: 8/2011
Document Id: 72a4ebde-71f4-4379-a2bd-9f147ae9dc00
Set id: e46b5e6f-2423-4382-9acf-a2e832bcf526
Version: 1
Effective Time: 20110830
 
ZION SYNTHETIC FIBER CO., LTD.