Label: BORN HAIR- panthenol shampoo

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 17, 2011

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  • ACTIVE INGREDIENT

    Active ingredients: d-Biotin, Nicontinamide, Panthenol, Zinc Pyrithione
  • DOSAGE & ADMINISTRATION

    - shampoo daily, gently massaging into moisten hair and scalp
    - leaving on for 3 to 5 minutes before rinsing
  • INACTIVE INGREDIENT

    inactive ingredient:  sodium laureth sulfate, cocamidopropyl betaine, edetate disodium, jojoba oil, arctium lappa root, water
  • PURPOSE

    - reduces dandruff and itching
    - increases hair longevity through palpation of cell metabolism
  • KEEP OUT OF REACH OF CHILDREN

    - keep out of reach of the children
  • INDICATIONS & USAGE

    - provides an excellent tonic effect and prevents depilation (hair-loss)
  • WARNINGS

    - stop using and see a doctor if hypersensitivity symptom continues
    - avoid storing under direct sun light or high temperature
  • PRINCIPAL DISPLAY PANEL

    label
  • INGREDIENTS AND APPEARANCE
    BORN HAIR 
    panthenol shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50653-4001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.6 g  in 100 g
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.06 g  in 100 g
    NADIDE (UNII: 0U46U6E8UK) (NADIDE - UNII:0U46U6E8UK) NADIDE0.3 g  in 100 g
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50653-4001-1100 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/09/2010
    Labeler - Bonogen Co., Ltd (688759463)