Your browser does not support JavaScript! DIABETIDERM ANTIFUNGAL (UNDECYLENIC ACID) CREAM [HEALTH CARE PRODUCTS]
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DIABETIDERM ANTIFUNGAL (undecylenic acid) cream
[Health Care Products]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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. 481:03 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

  • Plus Tea Tree Oil and Soothing Aloe Vera

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
 
Health Care Products

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