NDC Code(s) : 61995-2764-1
Packager : The Hain Celestial Group, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alba Acnedote Invisible TreatmentSalicylic Acid LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2764
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
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
BERGAMOT OIL(UNII: 39W1PKE3JI)
SALIX ALBA BARK(UNII: 205MXS71H7)
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
ORANGE OIL(UNII: AKN3KSD11B)
ALCOHOL(UNII: 3K9958V90M)
HAMAMELIS VIRGINIANA TOP WATER(UNII: NT00Y05A2V)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(UNII: R33S7TK2EP)
FILIPENDULA ULMARIA FLOWER(UNII: 06L18L32G6)
LENS CULINARIS FRUIT(UNII: ZYZ076G9JH)
ARNICA MONTANA FLOWER(UNII: OZ0E5Y15PZ)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
PEPPERMINT OIL(UNII: AV092KU4JH)
CHAMOMILE FLOWER OIL(UNII: 60F80Z61A9)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP(UNII: 9YT4B71U8P)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61995-2764-11 in 1 CARTON 10/01/2013
114 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 10/01/2013

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(61995-2764)

PRINCIPAL DISPLAY PANEL

carton label carton label