ADVANCED HERBAL CARE FOR THINNING-DAMAGED HAIR- pyrithione zinc shampoo 
B'IOTA Laboratories

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.

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Pyrithione Zinc 1.5%

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

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

For external use only.

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

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.  If swallowed get medical help or contact a Poison Control Center right away.

Directions

Store away from direct sunlight

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

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

B'IOTA Botanicals Herbal Care Experts

Advanced Herbal Care Daily Care Shampoo

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

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

Dandruff Shampoo

B'IOTA BOTANICALS

ADVANCED HERBAL CARE

for thinning-damaged 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

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)

Revised: 1/2018
Document Id: 75a43019-36aa-4245-bc67-854965b5eada
Set id: 91edba7b-8a3d-4a0e-8022-353e3ff54752
Version: 1
Effective Time: 20180116
 
B'IOTA Laboratories