NDC Code(s) : 61787-558-15
Packager : Health Care Products

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diaderm Antifungalundecylenic acid CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61787-558
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UNDECYLENIC ACID(UNII: K3D86KJ24N)
(UNDECYLENIC ACID - UNII:K3D86KJ24N) 		UNDECYLENIC ACID0.1 g in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF(UNII: ZY81Z83H0X)
ARGININE(UNII: 94ZLA3W45F)
CETYL ALCOHOL(UNII: 936JST6JCN)
CLOTRIMAZOLE(UNII: G07GZ97H65)
EDETATE DISODIUM(UNII: 7FLD91C86K)
LAVANDULA ANGUSTIFOLIA FLOWER(UNII: 19AH1RAF4M)
MELALEUCA ALTERNIFOLIA LEAF(UNII: G43C57162K)
METHYLPARABEN(UNII: A2I8C7HI9T)
EFLORNITHINE HYDROCHLORIDE(UNII: 4NH22NDW9H)
PEG-100 STEARATE(UNII: YD01N1999R)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
STEARIC ACID(UNII: 4ELV7Z65AP)
TROLAMINE(UNII: 9O3K93S3TK)
UREA(UNII: 8W8T17847W)
WATER(UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (2500000 MW)(UNII: 05I15JNI2J)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61787-558-151 in 1 CARTON
142 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 11/12/2013

PRINCIPAL DISPLAY PANEL

carton_558

NDC 61787-558-15

Diaderm

Antifungal Cream

Undecylenic Acid 10%

CURES TOE & FOOT FUNGAL INFECTIONS

NET WT 1.5 oz (42 g)