NDC Code(s) : 52125-624-60
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Permethrin Permethrin CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-624(NDC:0472-0242)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERMETHRIN(UNII: 509F88P9SZ)
(PERMETHRIN - UNII:509F88P9SZ) 		PERMETHRIN50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
CETETH-10(UNII: LF9X1PN3XJ)
WATER(UNII: 059QF0KO0R)
CETETH-20(UNII: I835H2IHHX)
LIGHT MINERAL OIL(UNII: N6K5787QVP)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
FORMALDEHYDE(UNII: 1HG84L3525)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)(UNII: Z135WT9208)
COCONUT OIL(UNII: Q9L0O73W7L)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
LANOLIN ALCOHOLS(UNII: 884C3FA9HE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-624-6060 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074806 12/03/2013

PRINCIPAL DISPLAY PANEL

DRUG: Permethrin


GENERIC: Permethrin


DOSAGE: CREAM


ADMINSTRATION: TOPICAL


NDC: 52125-624-60


ACTIVE INGREDIENT(S):

  • PERMETHRIN 50mg in 1g


INACTIVE INGREDIENT(S):

  • BUTYLATED HYDROXYTOLUENE
  • CETETH-10
  • WATER
  • CETETH-20
  • LIGHT MINERAL OIL
  • SODIUM HYDROXIDE
  • FORMALDEHYDE
  • CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)
  • COCONUT OIL
  • GLYCERIN
  • GLYCERYL MONOSTEARATE
  • ISOPROPYL MYRISTATE
  • LANOLIN ALCOHOLS


PACKAGING: 60 g in 1 TUBE




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