NDC Code(s) : 61995-1606-8
Packager : The Hain Celestial Group, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Avalon Organics AntidandruffSalicylic Acid SHAMPOO
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-1606
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID(UNII: O414PZ4LPZ)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		SALICYLIC ACID2 g in 414 g
Inactive Ingredients
Ingredient Name Strength
GERANIUM MACULATUM ROOT OIL(UNII: H2E371EDYX)
GLYCERYL OLEATE(UNII: 4PC054V79P)
LIMONENE, (+/-)-(UNII: 9MC3I34447)
SODIUM COCO-SULFATE(UNII: 3599J29ANH)
DISODIUM COCOYL GLUTAMATE(UNII: MBK0CP8F5A)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
COCO GLUCOSIDE(UNII: ICS790225B)
SODIUM SULFATE(UNII: 0YPR65R21J)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
WATER(UNII: 059QF0KO0R)
CHAMOMILE(UNII: FGL3685T2X)
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)
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)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
LAURYL GLUCOSIDE(UNII: 76LN7P7UCU)
HEXASODIUM PHYTATE(UNII: ZBX50UG81V)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61995-1606-8414 g in 1 BOTTLE Type 0: Not a Combination Product28/07/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M016 07/28/2016

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

REGISTRANT - The Hain Celestial Group, Inc.(081512382)

Establishment
Name Address ID/FEI Business Operations
The Hain Celestial Group, Inc. 081512382 manufacture(61995-1606)

Establishment
Name Address ID/FEI Business Operations
Belvedere International Inc 247836356 manufacture(61995-1606)

PRINCIPAL DISPLAY PANEL

AV36106 Label