NDC Code(s) : 52410-8020-4, 52410-8020-0
Packager : Shield Line LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AmeriDerm ZINC OXIDE OINTMENT
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52410-8020
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 OXIDE3.8 g in 100 g
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
CHLOROXYLENOL(UNII: 0F32U78V2Q)
CHOLECALCIFEROL(UNII: 1C6V77QF41)
CORN OIL(UNII: 8470G57WFM)
LANOLIN(UNII: 7EV65EAW6H)
MINERAL OIL(UNII: T5L8T28FGP)
PARAFFIN(UNII: I9O0E3H2ZE)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
SODIUM BORATE(UNII: 91MBZ8H3QO)
ALPHA-TOCOPHEROL(UNII: H4N855PNZ1)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
SODIUM LAURETH-3 SULFATE(UNII: BPV390UAP0)
STEARIC ACID(UNII: 4ELV7Z65AP)
GLYCERIN(UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
MICROCRYSTALLINE WAX(UNII: XOF597Q3KY)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
WATER(UNII: 059QF0KO0R)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52410-8020-4452 g in 1 JAR Type 0: Not a Combination Product01/01/2015
2NDC:52410-8020-0100 g in 1 TUBE Type 0: Not a Combination Product01/01/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M016 01/01/2015

LABELER - Shield Line LLC(078518916)

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