Label: REBIRTH HAIR- pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated August 30, 2011

If you are a consumer or patient please visit this version.

  • 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

    Image of carton

  • INGREDIENTS AND APPEARANCE
    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