NDC Code(s) : 61786-939-71
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TolnaftateTOLNAFTATE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-939(NDC:0904-0722)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLNAFTATE(UNII: 06KB629TKV)
(TOLNAFTATE - UNII:06KB629TKV) 		TOLNAFTATE10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CETETH-20(UNII: I835H2IHHX)
CHLOROCRESOL(UNII: 36W53O7109)
MINERAL OIL(UNII: T5L8T28FGP)
PETROLATUM(UNII: 4T6H12BN9U)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-939-7114.18 g in 1 TUBE Type 0: Not a Combination Product10/12/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 10/12/2016

PRINCIPAL DISPLAY PANEL

DRUG: Tolnaftate

GENERIC: TOLNAFTATE

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 61786-939-71

PACKAGING: 14.18 g in 1 TUBE

ACTIVE INGREDIENT(S):

  • TOLNAFTATE 10mg in 1g

INACTIVE INGREDIENT(S):

  • CHLOROCRESOL
  • PETROLATUM
  • MINERAL OIL
  • SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
  • CETETH-20
  • CETOSTEARYL ALCOHOL
  • PROPYLENE GLYCOL
  • WATER

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