AVALON ORGANICS ANTIDANDRUFF- salicylic acid shampoo

Avalon Organics Antidandruff by

Drug Labeling and Warnings

Avalon Organics Antidandruff 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.

ACTIVE INGREDIENT

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 *, Water (Aqua), Sodium Coco-Sulfate, Coco-Glucoside, Glyceryl Oleate, Salicylic Acid, Disodium Cocoyl Glutamate, 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, Melaleuca Alternifolia (Tea Tree) Leaf Oil *, Mentha Arvensis Leaf Oil, Mentha Piperita (Peppermint) Oil, Pogostemon Cablin Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Chamomilla Recutita (Matricaria) Flower Extract *, Chenopodium Quinoa Seed *, Rosmarinus Officinalis (Rosemary) Leaf Extract *, Styrax Benzoin Resin Extract, Tocopheryl Acetate, Babassu Oil Polyglyceryl-4 Esters, Bisabolol, Citric Acid, Inulin *, Menthol, Potassium Hydroxide, Sodium Cocoyl Glutamate, Sodium Cocoyl Threoninate, Sodium Sulfate, Alcohol *, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Benzyl Alcohol, Benzyl Benzoate, Cinnamyl Alcohol, Citral, Citronellol, Coumarin, Geraniol, Isoeugenol, Limonene, Linalool.

(1) Certified Organic Ingredient

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AVALON ORGANICS ANTIDANDRUFF 
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-1606
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 g  in 414 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM SULFATE (UNII: 0YPR65R21J)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
COCO GLUCOSIDE (UNII: ICS790225B)
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)
INULIN (UNII: JOS53KRJ01)
MENTHOL (UNII: L7T10EIP3A)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)
GLYCERYL OLEATE (UNII: 4PC054V79P)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
SODIUM COCO-SULFATE (UNII: 3599J29ANH)
DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-1606-8	414 g in 1 BOTTLE; Type 0: Not a Combination Product	07/28/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/28/2016

Labeler - The Hain Celestial Group, Inc. (117115556)

Registrant - The Hain Celestial Group, Inc. (014334364)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		014334364	manufacture(61995-1606)