AT ONE WITH NATURE DRY AND ITCHY SCALP- pyrithione zinc shampoo 
BIOCARE LABS INC.

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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Active Ingredients:

Pyrithione Zinc 1%

Purpose: Antidandruff, Anti-Seborrheic Dermatitis

Use: Help prevent recurrence of flaking and itching associated with dandruff.

Warnings:

When using this product

Ask a doctor. before using this product if condition covers a large area of body.

Stop use and ask a doctor if. conditions worsens or does not improve after regular use as directed.

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

Directions

Inactive Ingredients

Water(Aqua), Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Cocamide DEA, Polyquaternium-28, Cocamidopropyl Betaine,Menthol,Glycol Stearate, Magnesium Aluminum Silicate, Dihydrogenated Tallow Phthalic Acid, Propylene Glycol, Lamium Album Flower Extract, Pinus Sylvestris Cone Extract, Arctium Lappa(Burdock) Root Extract, Anthemis Nobilis(Chamomile) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Hedra Helix (Ivy) Leaf/Stem Extract, Arnica Montana Flower Extract, Nasturtium Officinale (Watercress) Flower/Leaf Extract, Allium Sativum (Garlic) Bulb Extract, Calendula Officinalis (Pot Marigold) Flower Extract, Tilia Cordata (Linden) Flower Extract, Centaurea Cyanus (Cornflower) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Hypericum Perfratum (St. John's Wort) Flower/Leaf/Stem Extract, Fragrance, DMDM Hydantion, Tetraodium EDTA, Citric Acid, Blue 1 (CI 42090) Argania spinosa (Argan) KERNEL Oil


Biocare Shampoo 8 oz

Biocare Shampoo 16 oz

AT ONE WITH NATURE  DRY AND ITCHY SCALP
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54602-758
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE (UNII: 1R81RPY10G)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
MENTHOL (UNII: L7T10EIP3A)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
LAMIUM ALBUM (UNII: 046Y1357I6)  
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
POLYQUATERNIUM-28 (1100000 MW) (UNII: 6M8B654MEQ)  
ARGAN OIL (UNII: 4V59G5UW9X)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
ROSEMARY (UNII: IJ67X351P9)  
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)  
GARLIC (UNII: V1V998DC17)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
CHAMOMILE (UNII: FGL3685T2X)  
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54602-758-08237 mL in 1 BOTTLE
2NDC:54602-758-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/20/2009
Labeler - BIOCARE LABS INC. (798953493)
Registrant - RAANI CORPORATION (067084681)
Establishment
NameAddressID/FEIBusiness Operations
RAANI CORPORATION067084681manufacture(54602-758)

Revised: 12/2012
Document Id: 3398bb40-df14-494e-9e1f-619629b94979
Set id: 48da6e99-10d3-41fe-9e56-9dd98568dd7d
Version: 1
Effective Time: 20121227
 
BIOCARE LABS INC.