Label: REBIRTH HAIR TONIC- witch hazel solution

  • 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 September 18, 2011

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

  • 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

    Image of carton

  • INGREDIENTS AND APPEARANCE
    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