NDC Code(s) : 35356-855-05
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MEDROXMENTHOL, CAPSAICIN PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-855(NDC:45861-014)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL5 g in 100 g
CAPSAICIN(UNII: S07O44R1ZM)
(CAPSAICIN - UNII:S07O44R1ZM) 		CAPSAICIN0.0375 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
EDETATE DISODIUM(UNII: 7FLD91C86K)
DIAZOLIDINYL UREA(UNII: H5RIZ3MPW4)
METHYLPARABEN(UNII: A2I8C7HI9T)
IODOPROPYNYL BUTYLCARBAMATE(UNII: 603P14DHEB)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-855-055 in 1 BOX
110 g in 1 PATCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 06/13/2012

PRINCIPAL DISPLAY PANEL

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