NDC Code(s) : 61995-2436-9
Packager : The Hain Celestial Group, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AL0043600 Alba Botanica VE Herbal Healing BodyColloidal Oatmeal LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2436
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OATMEAL(UNII: 8PI54V663Y)
(OATMEAL - UNII:8PI54V663Y) 		OATMEAL0.4 g in 100 g
Inactive Ingredients
Ingredient Name Strength
MANDARIN OIL(UNII: NJO720F72R)
EUCALYPTUS GLOBULUS LEAF(UNII: S546YLW6E6)
ROSEMARY OIL(UNII: 8LGU7VM393)
BAMBUSA ARUNDINACEA STEM(UNII: NRA4497HC5)
ORANGE OIL(UNII: AKN3KSD11B)
CANNABIS SATIVA SEED OIL(UNII: 69VJ1LPN1S)
LIME OIL(UNII: UZH29XGA8G)
BERGAMOT OIL(UNII: 39W1PKE3JI)
GRAPEFRUIT OIL(UNII: YR377U58W9)
LEMON OIL(UNII: I9GRO824LL)
APRICOT KERNEL OIL(UNII: 54JB35T06A)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
RUBUS FRUTICOSUS WHOLE(UNII: 0XZA1262YF)
COCONUT OIL(UNII: Q9L0O73W7L)
SAFFLOWER OIL(UNII: 65UEH262IS)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
YELLOW WAX(UNII: 2ZA36H0S2V)
CETYL ALCOHOL(UNII: 936JST6JCN)
ALCOHOL(UNII: 3K9958V90M)
BENZYL ALCOHOL(UNII: LKG8494WBH)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
GLYCERIN(UNII: PDC6A3C0OX)
SUNFLOWER OIL(UNII: 3W1JG795YI)
WATER(UNII: 059QF0KO0R)
SHEA BUTTER(UNII: K49155WL9Y)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
GLYCERYL STEARATE SE(UNII: FCZ5MH785I)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
CHAMOMILE(UNII: FGL3685T2X)
XANTHAN GUM(UNII: TTV12P4NEE)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
SODIUM BENZOATE(UNII: OJ245FE5EU)
BIOTIN(UNII: 6SO6U10H04)
BETULA PENDULA LEAF(UNII: 5HW39H9KDH)
TURMERIC(UNII: 856YO1Z64F)
ROSA CENTIFOLIA FLOWER OIL(UNII: H32V31VMWY)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
CITRUS AURANTIUM FRUIT OIL(UNII: 59JDQ5VT0T)
MENTHA CITRATA LEAF(UNII: ZMA317E4J7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61995-2436-9907 g in 1 BOTTLE, PUMP Type 0: Not a Combination Product09/12/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 09/12/2017

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

REGISTRANT - The Hain Celestial Group, Inc.(201360821)

Establishment
Name Address ID/FEI Business Operations
The Hain Celestial Group, Inc 201360821 manufacture(61995-2436)

PRINCIPAL DISPLAY PANEL

bottle label