NDC Code(s) : 61995-2753-6
Packager : The Hain Celestial Group, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alba Natural Acnedote AstringentSalicylic Acid LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2753
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
ARNICA MONTANA FLOWER WATER(UNII: U7L2JP51PR)
WATER(UNII: 059QF0KO0R)
MYRICA ESCULENTA FRUIT(UNII: JKM8M5F55D)
LINALOOL, (+)-(UNII: F4VNO44C09)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
CAMELLIA SINENSIS WHOLE(UNII: C5M4585ZBZ)
SORBITOL(UNII: 506T60A25R)
SODIUM BENZOATE(UNII: OJ245FE5EU)
LIMONENE, (+)-(UNII: GFD7C86Q1W)
ALCOHOL 95%(UNII: 7528N5H79B)
ORANGE PEEL(UNII: TI9T76XD44)
PEPPERMINT OIL(UNII: AV092KU4JH)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
TERT-BUTYL ALCOHOL(UNII: MD83SFE959)
GLYCERIN(UNII: PDC6A3C0OX)
FILIPENDULA ULMARIA WHOLE(UNII: 3LH0M209LN)
MATRICARIA CHAMOMILLA(UNII: G0R4UBI2ZZ)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
LAVENDER OIL(UNII: ZBP1YXW0H8)
WILLOW BARK(UNII: S883J9JDYX)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
DENATONIUM BENZOATE(UNII: 4YK5Z54AT2)
CITRUS AURANTIUM FRUIT OIL(UNII: 59JDQ5VT0T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61995-2753-6177 g in 1 BOTTLE Type 0: Not a Combination Product20/07/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M032 01/21/2010

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. 081512382 manufacture(61995-2753)

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