NDC Code(s) : 61995-2060-6
Packager : The Hain Celestial Group, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AL0076001 Alba Botanica Acnedote Deep Pore WashSalicylic Acid LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2060
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 100 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL 95%(UNII: 7528N5H79B)
CITRAL(UNII: T7EU0O9VPP)
COCO-BETAINE(UNII: 03DH2IZ3FY)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
WATER(UNII: 059QF0KO0R)
DISODIUM COCOYL GLUTAMATE(UNII: MBK0CP8F5A)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
GLYCERIN(UNII: PDC6A3C0OX)
HAMAMELIS VIRGINIANA TOP WATER(UNII: NT00Y05A2V)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
AZADIRACHTA INDICA LEAF(UNII: HKY915780T)
BERGAMOT OIL(UNII: 39W1PKE3JI)
PEPPERMINT OIL(UNII: AV092KU4JH)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
CAMELLIA SINENSIS WHOLE(UNII: C5M4585ZBZ)
TERT-BUTYLBENZOIC ACID (MIXED ISOMERS)(UNII: UGL7Q68L1S)
WILLOW BARK(UNII: S883J9JDYX)
DEHYDROACETIC ACID(UNII: 2KAG279R6R)
SODIUM BENZOATE(UNII: OJ245FE5EU)
ORANGE PEEL(UNII: TI9T76XD44)
MELISSA OFFICINALIS LEAF(UNII: 50D2ZE9219)
PARSLEY OIL(UNII: IXK9N7RJ7J)
URTICA DIOICA LEAF(UNII: X6M0DRN46Q)
LIMONENE, (+)-(UNII: GFD7C86Q1W)
LINALOOL, (+)-(UNII: F4VNO44C09)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61995-2060-6177 g in 1 BOTTLE Type 0: Not a Combination Product29/11/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M006 11/29/2017

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(61995-2060)

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