NDC Code(s) : 42957-001-01
Packager : EXPRO3 LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BabySpa Zinc Oxide CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42957-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide120 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SHEA BUTTER(UNII: K49155WL9Y)
ALOE VERA FLOWER(UNII: 575DY8C1ER)
COCOA BUTTER(UNII: 512OYT1CRR)
YELLOW WAX(UNII: 2ZA36H0S2V)
STARCH, POTATO(UNII: 8I089SAH3T)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
GRAPE SEED OIL(UNII: 930MLC8XGG)
KAOLIN(UNII: 24H4NWX5CO)
SESAME OIL(UNII: QX10HYY4QV)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
CALENDULA OFFICINALIS SEED OIL(UNII: 9JS8DS42SV)
WATER(UNII: 059QF0KO0R)
PROPYL GALLATE(UNII: 8D4SNN7V92)
LAURYL GLUCOSIDE(UNII: 76LN7P7UCU)
EPIGALLOCATECHIN GALLATE(UNII: BQM438CTEL)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
OLIVE OIL(UNII: 6UYK2W1W1E)
GLYCERIN(UNII: PDC6A3C0OX)
CHAMAEMELUM NOBILE FLOWER(UNII: O2T154T6OG)
BENZOIC ACID(UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID(UNII: 2KAG279R6R)
BORAGE OIL(UNII: F8XAG1755S)
OENOTHERA BIENNIS(UNII: 76UI55V071)
LAVANDULA ANGUSTIFOLIA FLOWER(UNII: 19AH1RAF4M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42957-001-01100 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/18/2012

LABELER - EXPRO3 LLC(014904067)

REGISTRANT - E.L. Erman Cosmetic Manufacturing Ltd(531894152)

Establishment
Name Address ID/FEI Business Operations
E.L. Erman Cosmetic Manufacturing Ltd 531894152 manufacture(42957-001)

PRINCIPAL DISPLAY PANEL

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