Label: SABIWAY, HAIR RE-GROWTH (rosemary- rosmarinus officinalis leaf extract shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated March 9, 2016

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  • ACTIVE INGREDIENT

    Active ingredient

    Rosemary (Rosmarinus officinalis) leaf extract, 1X

  • PURPOSE

    Purpose

    Hair Re-Growth

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    • Keep bottle tightly closed and out of reach of childeren, If swallowed, get medical help or contact a Poison Control Center right away.
  • INDICATIONS & USAGE

    Uses

    • Help Hair Re-Growth
  • WARNINGS

    Warnings

    For external use only

    • avoid contact with eyes, if that occures, rinse with plenty of water
    • ask a doctor before use if ou have Psoriasis
    • stop use and ask a doctor if too much scalp irritation or sensitivity develops or increases
  • DOSAGE & ADMINISTRATION

    Directions

    • Shake well before applying
    • apply onto wet hair
    • provide a gentle massage with teh fingertips
    • rinse with plenty of water

    Adults and Childrebn 12 years and older

    • adult apply each day and leave applied 5 minutes
    • start with 1 application daily, then gradually increase 2 times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day

    Children under 12 years

    • Children under 12 years, apply each day and leave one minute applied
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Aloe vera (aloe barbadensis extract), ascorbic acid, citric acid, cyanocobalamin, fragrance, methylparaben, olive (olea europaea) oil, potassium chloride, potassium hydroxide, propylparaben, sodium laureth sulfate, sodium lauryl sulfate, tocopherol, water

  • PRINCIPAL DISPLAY PANEL

    Sabiway PDP Sabiway Drug Facts Panel

  • INGREDIENTS AND APPEARANCE
    SABIWAY, HAIR RE-GROWTH 
    rosemary (rosmarinus officinalis) leaf extract shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70527-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROSEMARY (UNII: IJ67X351P9) (ROSEMARY - UNII:IJ67X351P9) ROSEMARY1 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CYANOCOBALAMIN (UNII: P6YC3EG204)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70527-001-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/09/2016
    Labeler - Navarrete Estacio Fernando (880278943)
    Establishment
    NameAddressID/FEIBusiness Operations
    Navarrete Estacio Fernando880278943manufacture(70527-001)
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