Label: AT ONE WITH NATURE DRY AND ITCHY SCALP- 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 December 27, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Pyrithione Zinc 1%

  • PURPOSE

    Purpose: Antidandruff, Anti-Seborrheic Dermatitis

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings:

    • For external use only.

  • WHEN USING

    When using this product

    • Avoid getting into eyes. In event of contact, rinse eyes thoroughly with water.

  • ASK DOCTOR

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

  • STOP USE

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Shake before using.
    • Wet hair thoroughly, and apply shampoo.Work up a rich lather, and massage the scalp with fingertips. Rinse and lather again.Allow second lather to stay on hair for 5 minutes.Rinse thoroughly and apply AtOne with Nature ItchyScalp Conditioner and rinse, or Leave-In Conditioner.Proceed to style.
    • For best results, use at least twice a week or as directed by a doctor.
  • INACTIVE INGREDIENT

    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

  • PRINCIPAL DISPLAY PANEL


    Biocare Shampoo 8 oz

    Biocare Shampoo 16 oz

  • INGREDIENTS AND APPEARANCE
    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)
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