ANTI DANDRUFF- salicylic acid rinse

Anti Dandruff by

Drug Labeling and Warnings

Anti Dandruff by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

For external use only. Avoid contact with eyes. Rinse eyes throughly with water in case contact ossurs. Discontinue to use and contact your physician if irritation develops.

Drug Facts

Salicylic Acid    2.0%

PURPOSE

Controls symptoms of dandruff, seboric dermatitis and psoriasis

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

For relief of flaking, scaling and itching associated with dandruff. Helps prevent Seborrheic Dermatitis

DOSAGE & ADMINISTRATION

For the best results use at least three times each week. Apply to clean, wet hair. Rinse throughly.

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Juice (1), Aqua (Water), Glyceryl Stearate SE, Caprylic/Capric Triglyceride, Stearic Acid,Cetyl Alcohol, Capryloyl Glycerin/Sebacic Acid Copolymer, Helianthus Annuus (Sunflower Seed Oi (1), Diheptyl Succinate, Stearyl Alcohol, Olea Europaea (Olive) Fruit Oil (1l, Simmondsia Chinensis (Jojoba) Seed Oil (1), Butyrospermum Parkii (Shea) Butter (1), Chamomilla Recuitita (Matricaria) Flower Extract (1), Eucalyptus Globulus Leaf Extract (1), Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract (1), Rosmarinus Officinalis (Rosemmary) Leaf Extract (1), Styrax Benzoin Resin Extract, Malaleuca Alternifolia (Tea Tree) Leaf Oil (1), Rosmarinus Officinalis (Rosemary) Leaf Oil , Cedrus Atlantica Bark Oil, Citrus Aurantium Dulcis (Orange Peel Oil, Citrus Limon (Lemon) Peel Oil, Copaifera Officinalis (Balsam Copaiba) Resin, Coriandrum Sativum (Coriander) Fruit Oil, Geranium Maculatum Oil, Lavandula Angustifolia  (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Pogostemon Cablin Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Hydrolyzed Wheat Protein, Menthol, Tocopheryl Acetate, Xanthan Gum, Alcohol, Benzyl Alcohol, Sodium Benzoate, Potassium Sorbate

(1) Certified Organic Ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTI DANDRUFF 
salicylic acid rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-1107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2.0 g  in 397 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
SUNFLOWER OIL (UNII: 3W1JG795YI)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
OLIVE OIL (UNII: 6UYK2W1W1E)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
CHAMOMILE (UNII: FGL3685T2X)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)
STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)
ORANGE OIL (UNII: AKN3KSD11B)
LEMON OIL (UNII: I9GRO824LL)
COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT)
CORIANDER OIL (UNII: 7626GC95E5)
GERANIUM MACULATUM WHOLE (UNII: LFG25P7V8M)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
POGOSTEMON CABLIN WHOLE (UNII: H6UKY25H2P)
ROSEMARY OIL (UNII: 8LGU7VM393)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
MENTHOL (UNII: L7T10EIP3A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-1107-9	397 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/17/2014

Labeler - The Hain Celestial Group, Inc. (858894996)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		858894996	manufacture(61995-1107)