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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Active ingredient

Undecylenic Acid 10%

Purpose

Antifungal

Uses

cures most athlete's foot
cures most jock itch and ringworm
relieves itching, burning, cracking, and scaling which accompany these conditions

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

wash the affected area and dry thoroughly
apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
Supervise children in the use of this product.
for athletes foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor.
this product is not effective on the scalp or nails
wash hands after each use

Other information

store between 2° and 30°C (36° and 86°F).

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. 481:02 4/11

Package/Label Principal Display Panel

PODIATRIST RECOMMENDED

DiabetiDerm® Antifungal Cream

contains Undecylenic Acid 10% and

L-Arginine HCl

KILLS TOENAIL & FOOT FUNGUS

Plus Tea Tree Oil and Soothing Aloe Vera

NET WT 1.5 OZ (42 g)

DIABETIDERM ANTIFUNGAL
undecylenic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61787-481
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNDECYLENIC ACID)	UNDECYLENIC ACID	0.1 g in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:61787-481-15	1 TUBE in 1 CARTON	contains a TUBE
1		42 g in 1 TUBE	This package is contained within the CARTON (61787-481-15)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	07/01/2007

Labeler - Health Care Products (101196749)

Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)

Establishment
Name	Address	ID/FEI	Operations
San-Mar Laboratories, Inc.		078718053	MANUFACTURE

Revised: 07/2011 Health Care Products