NDC Code(s) : 52125-265-01
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Mometasone Furoate Mometasone Furoate OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-265(NDC:67405-300)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mometasone Furoate(UNII: 04201GDN4R)
(MOMETASONE - UNII:8HR4QJ6DW8) 		Mometasone Furoate1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Hexylene Glycol(UNII: KEH0A3F75J)
Stearyl Alcohol(UNII: 2KR89I4H1Y)
Phosphoric Acid(UNII: E4GA8884NN)
Water(UNII: 059QF0KO0R)
PROPYLENE GLYCOL MONOPALMITOSTEARATE(UNII: F76354LMGR)
White Wax(UNII: 7G1J5DA97F)
Petrolatum(UNII: 4T6H12BN9U)
Titanium Dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-265-0115 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077401 06/17/2013

PRINCIPAL DISPLAY PANEL

DRUG: Mometasone Furoate


GENERIC: Mometasone Furoate


DOSAGE: OINTMENT


ADMINSTRATION: TOPICAL


NDC: 52125-265-01


ACTIVE INGREDIENT(S):

  • Mometasone Furoate 1mg in 1g


INACTIVE INGREDIENT(S):

  • Hexylene Glycol
  • Stearyl Alcohol
  • Phosphoric Acid
  • Water
  • PROPYLENE GLYCOL MONOPALMITOSTEARATE
  • White Wax
  • Petrolatum
  • Titanium Dioxide


PACKAGING: 15 g in 1 TUBE



/xml/2b9d91e1-6bbc-49f2-8913-998aa0f1989c/MM2.jpg

/xml/2b9d91e1-6bbc-49f2-8913-998aa0f1989c/MM2.jpg