DIABETIDERM ANTIFUNGAL- undecylenic acid cream 
Health Care Products

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Undecylenic Acid 10%

Purpose

Antifungal

Uses

Warnings

For external use only.

Do not use

  • on children under 2 years of age unless directed by a doctor
  • for vaginal yeast infections

When using this product

do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and consult a doctor if

irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Aloe Vera, Arginine, Cetyl Alcohol, Clotrimazole, Coco-Caprylate/Caprate, Disodium EDTA, Glyceryl Stearate, Lavender Oil, Methylparaben, Ornithine HCl, PEG-100 Stearate, Propylparaben, Sodium Polyacrylate, Sorbitan Stearate, Stearic Acid, Tea Tree Oil, Triethanolamine, Urea, Water.

Questions or comments?

Call: 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number.

Rev. 481:03 4/12

Package/Label Principal Display Panel

Image of Carton - 42 g

 PODIATRIST RECOMMENDED

DiabetiDerm® Antifungal Cream

contains Undecylenic Acid 10% and

L-Arginine HCl

KILLS TOENAIL & FOOT FUNGUS

NET WT 1.5 OZ (42 g)

DIABETIDERM ANTIFUNGAL 
undecylenic acid cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61787-481
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID0.1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ARGININE 
CETYL ALCOHOL 
CLOTRIMAZOLE 
EDETATE DISODIUM 
GLYCERYL MONOSTEARATE 
LAVANDULA ANGUSTIFOLIA FLOWER 
MELALEUCA ALTERNIFOLIA LEAF 
METHYLPARABEN 
EFLORNITHINE HYDROCHLORIDE 
PEG-100 STEARATE 
PROPYLPARABEN 
SORBITAN MONOSTEARATE 
STEARIC ACID 
TROLAMINE 
UREA 
WATER 
SODIUM POLYACRYLATE (2500000 MW) 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61787-481-151 in 1 CARTON
142 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C07/01/200712/31/2014
Labeler - Health Care Products (101196749)
Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
NameAddressID/FEIBusiness Operations
Process Technologies & Packaging, LLC809172885MANUFACTURE(61787-481)

Revised: 11/2013
Document Id: 5d536d52-b5b6-457e-b56c-f8c184e9c457
Set id: a32eafa4-0c4f-4c62-a00b-33066572514a
Version: 3
Effective Time: 20131108
 
Health Care Products