ANTI DANDRUFF- salicylic acid shampoo

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. Wet hair, lather, massage onto scalp. Rinse and repeat if desired.

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Juice (1),Aqua (Water), Sodium Coco-Sulfate, Cococ-Glucoside, Glyceryl Oleate, Chamomilla Recuitita (Matricaria) Flower Extract (1), Malaleuca Alternifolia (Tea Tree) Leaf Oil (1), Rosmarinus Officinalis (Rosemary) extract, Styrax Benzoin Resin Extract (1), Canarium Luzonicum Gum Nonvolatiles, Cedrus Atlantica Bark Oil, Citrus Aurantium Dulcis (Orange Peel Oil, Citrus Limon (Lemon) Peel Oil,

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTI DANDRUFF 
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-1106
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 414 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
SODIUM COCO-SULFATE (UNII: 3599J29ANH)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERYL OLEATE (UNII: 4PC054V79P)
CHAMOMILE (UNII: FGL3685T2X)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)
STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)
CANARIUM LUZONICUM WHOLE (UNII: 5BH1ESR432)
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 ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
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)
INULIN (UNII: JOS53KRJ01)
MENTHOL (UNII: L7T10EIP3A)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
SODIUM SULFATE (UNII: 0YPR65R21J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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: 61995-1106-9	414 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/29/2014

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

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		858894996	manufacture(61995-1106)