NDC Code(s) : 61995-1607-8
Packager : The Hain Celestial Group, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Avalon Organics Antidandruff ConditionerSalicylic Acid RINSE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-1607
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 397 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)
BRASSICA JUNCEA SEED OIL(UNII: 4D13WHP5F7)
CHENOPODIUM QUINOA SEED(UNII: OO4K72NZ2X)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)(UNII: N7YC58165T)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
WATER(UNII: 059QF0KO0R)
GLYCERYL STEARATE SE(UNII: FCZ5MH785I)
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)
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)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES(UNII: U72Q2I8C85)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
LIMONENE, (+)-(UNII: GFD7C86Q1W)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61995-1607-8397 g in 1 BOTTLE Type 0: Not a Combination Product24/08/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M016 08/24/2016

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(61995-1607)

Establishment
Name Address ID/FEI Business Operations
Belvedere International Inc. 247836356 manufacture(61995-1607)

PRINCIPAL DISPLAY PANEL

AV36107 Label