Label: ADVANCED HERBAL CARE FOR THINNING-DAMAGED 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 January 16, 2018

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

  • ACTIVE INGREDIENT

    Pyrithione Zinc 1.5%

  • PURPOSE

    Pyrithione Zinc 1.5%.............Antidandruff

  • INDICATIONS & USAGE

    Helps eliminate and reduces the recurrence of scalp itching, irritation, redness, flaking and scaling associated with dandruff.

  • WARNINGS

    For external use only.

  • WHEN USING

    When using this product avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • apply a tablespoon of shampoo to wet hair and gently massage the scalp with fingertips for 1.5 to 2 minutes and rinse well
    • for best results use at least twice a week or as directed by a doctor
  • STORAGE AND HANDLING

    Store away from direct sunlight

  • INACTIVE INGREDIENT

    WATER/AQUA,SODIUM LAURETH SULFATE, SODIUM CHLORIDE, COCAMIDOPROPYL BETAINE, HERBAL BIOCOMPLEX B11 (URTICA URENS LEAF EXTRACT, URTICA DIOICA (NETTLE) EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, CERATONIA SILIQUA (CAROB) FRUIT EXTRACT, EQUISETUM ARVENSE EXTRACT), ZINC PYRITHIONE, BENZYL ALCOHOL, FRAGRANCE/PARFUM, CARBOMER, PROPYLENE GLYCOL, HYDROXYPROPYL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, AMODIMETHICONE, TETRASODIUM EDTA, MEL, C11-15 PARETH-7, LAURETH-9, BUTYLPHENYL METHYLPROPIONAL, GLYCERIN, COUMARIN, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, TRIDECETH-12, VITIS VINIFERA SEED EXTRACT, METHYLCHLOROISOTHIAZOLIN, METHYLISOTHIAZOLINONE

  • QUESTIONS

    Toll Free 1-855-246-8291 Monday through Friday, 9am-5pm

  • DESCRIPTION

    B'IOTA Botanicals Herbal Care Experts

    Advanced Herbal Care Daily Care Shampoo

    • Dermatolgist tested formulat for thinning-damaged hair that revitalizes the appearance of hair while increasing volume and thickness for fuller and stronger looking hair
    • Strengthens hair
    • Hypoallergenic
    • Perfect for women & men
    • Extracts from plants
    • No known side effects
    • Safe for all hair types & textures
    Clinically Tested*
    97% More than 97% of subjects reported thicker, fuller and stronger looking hair when using shampoo and serum combined.*
    83% More than 83% of subjects reported thicker, fuller and stronger looking hair when using only BIOTA Herbal Shampoo.*
    *Results of a 6-month, placebo-controlled, independent clinical study using BIOTA Botanicals Advanced Herbal Care Shampoo and Leave-In Serum.

    For best results, use daily and in conjunction with BIOTA Botanicals Advanced Herbal Conditioner and Leave-In Serum

    Directions for use

    Apply BIOTA Botanicals Herbal Shampoo for thinning-damaged hair to wet hair. Gently massage into the scalp for 1 1/2-to-2 minutes. Rinse well. Repeat if desired.

    Distributed by:
    B'IOTA International LLC
    369 Lexington Avenue, New York, NY 10017

    Product of Turkey

    www.biotaUSA.com
    Toll Free 855-246-8291

  • DESCRIPTION

    WHAT CAUSES THINNING-DAMAGED HAIR?

    It’s completely natural for hair to thin over time. Changes in hair volume can happen for many reasons including diet, stress, over-treatment, over-styling and the sun among other causes.


    WHAT IS ADVANCED HERBAL CARE?

    BIOTA Botanicals Advanced Herbal Care is our line of Shampoos, Conditioner and Leave-In Serum for thinning-damaged hair. The rich, herbal blends found in BIOTA Botanicals Advanced Herbal Care are derived from ingredients found in nature, many of which date back to ancient Mesopotamia and have long been part of European beauty secrets and body care rituals from the distant past.

    All of our hair care products are made with an exclusive combination of herbal extracts. BIOTA Botanicals Advanced Herbal Care was specifically formulated to help combat and bring new hope to those experiencing thinning-damaged hair. Regular and continued use revitalizes the appearance of hair and
    • Promotes Stronger
    • Nourishes Healthier
    • Encourages Thicker & Fuller Looking Hair


    BIOTA Botanical Laboratories, the leading and trusted herbal care experts, is committed to marrying science with nature to create the exclusive, clinically tested blend found in Advanced Herbal Care.


    BIOTA BOTANICALS AROUND THE WORLD


    Loyal BIOTA customers around the world tell us how effective our products are. Now you can get to know the rich, luxurious and aromatic experience of our plant-based, easy-to-use Advanced Herbal Care Shampoo, Conditioner and Leave-In Serum for thinning-damaged hair.

    NEW HOPE FOR FULLER, STRONGER AND THICKER LOOKING HAIR


    All of BIOTA Botanicals Advanced Herbal Care products contains our exclusive, scientificallyformulated Herbal BioComplex B11, a clinically tested combination of herbal extracts with naturally occurring minerals and essential fatty acids that work by nourishing the scalp.

    This powerful blend brings new hope to those who want to combat thinning- damaged hair, helping in the fight to maintain and encourage
    stronger, more resilient hair and can only be found in BIOTA Botanicals’ products.


    HERBAL CARE,
    DERMATOLOGIST TESTED
    • Hypoallergenic
    • Paraben Free
    • Phthalate Free

  • PRINCIPAL DISPLAY PANEL

    Dandruff Shampoo

    B'IOTA BOTANICALS

    ADVANCED HERBAL CARE

    for thinning-damaged hair

    • Promotes Stronger
    • Nourishes Healthier
    • Encourages Thicker & Fuller Looking Hair

    Clinically Tested 97% reported Stronger, Thicker, Fuller Looking Hair*

    Daily Care Shampoo

    Contains the exclusive ingredient

    Effective - Clinically Tested*

    HERBAL BIOCOMPLEX B11

    B'IOTA 59 Elements

    10.1 fl oz (300 mL)

    Dandruff Label

  • INGREDIENTS AND APPEARANCE
    ADVANCED HERBAL CARE  FOR THINNING-DAMAGED HAIR
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23637-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.15 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    URTICA URENS LEAF (UNII: 0DCW2P163M)  
    URTICA DIOICA ROOT (UNII: J8HE8A6E5T)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    CAROB (UNII: 5MG5Z946UO)  
    EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROXYPROPYLTRIMONIUM CHLORIDE FRAGMENT (UNII: N30M4819DB)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    HONEY (UNII: Y9H1V576FH)  
    C11-15 PARETH-7 (UNII: 261HPE0IS3)  
    POLIDOCANOL (UNII: 0AWH8BFG9A)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COUMARIN (UNII: A4VZ22K1WT)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    TRIDECETH-12 (UNII: YFY3KG5Y7O)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23637-002-011 in 1 CARTON01/16/2018
    1300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/16/2018
    Labeler - B'IOTA Laboratories (968738240)
    Registrant - B'IOTA Laboratories (968738240)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIOTA BITKISEL ILAC VE KOZMETIK LABORATUARLARI TICARET A S566215073manufacture(23637-002)