Label: ADVANCED HERBAL CARE FOR THINNING-DAMAGED HAIR- pyrithione zinc shampoo
- NDC Code(s): 23637-002-01
- Packager: B'IOTA Laboratories
- 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.
Updated January 16, 2018
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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
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
- Perfect for women & men
- Extracts from plants
- No known side effects
- Safe for all hair types & textures
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.
B'IOTA International LLC
369 Lexington Avenue, New York, NY 10017
Product of Turkey
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.
• Paraben Free
• Phthalate Free
PRINCIPAL DISPLAY PANEL
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)