AT ONE WITH NATURE DRY AND ITCHY SCALP- pyrithione zinc shampoo

AT ONE WITH NATURE by

Drug Labeling and Warnings

AT ONE WITH NATURE by is a Otc medication manufactured, distributed, or labeled by BIOCARE LABS INC., RAANI CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

AT ONE WITH NATURE  DRY AND ITCHY SCALP
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54602-758
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54602-758-08	237 mL in 1 BOTTLE
2	NDC: 54602-758-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/20/2009

Labeler - BIOCARE LABS INC. (798953493)

Registrant - RAANI CORPORATION (067084681)

Establishment
Name	Address	ID/FEI	Business Operations
RAANI CORPORATION		067084681	manufacture(54602-758)