ADVANCED HERBAL CARE FOR THINNING-DAMAGED HAIR- pyrithione zinc shampoo

Advanced Herbal Care by

Drug Labeling and Warnings

Advanced Herbal Care by is a Otc medication manufactured, distributed, or labeled by B'IOTA Laboratories, BIOTA BITKISEL ILAC VE KOZMETIK LABORATUARLARI TICARET A S. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

ADVANCED HERBAL CARE  FOR THINNING-DAMAGED HAIR
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23637-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.15 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23637-002-01	1 in 1 CARTON	01/16/2018
1		300 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/16/2018

Labeler - B'IOTA Laboratories (968738240)

Registrant - B'IOTA Laboratories (968738240)

Establishment
Name	Address	ID/FEI	Business Operations
BIOTA BITKISEL ILAC VE KOZMETIK LABORATUARLARI TICARET A S		566215073	manufacture(23637-002)