Skip to Content

Diaderm Antifungal

Dosage form: cream
Ingredients: UNDECYLENIC ACID 0.1g in 1g
Labeler: Health Care Products
NDC Code: 61787-558

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.

Drug Facts

Active ingredient

Undecylenic Acid 10 %

Purpose

Antifungal

Keep Out of Reach of Children

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: 1-866-263-9003, 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. 558:00 8/13

Package/Label Principal Display Panel

NDC 61787-558-15

Diaderm

Antifungal Cream

Undecylenic Acid 10%

CURES TOE & FOOT FUNGAL INFECTIONS

NET WT 1.5 oz (42 g)

DIADERM ANTIFUNGAL 
undecylenic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-558
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 
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 Description
1NDC:61787-558-151 TUBE in 1 CARTON
142 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/12/2013
Labeler - Health Care Products (101196749)
Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
NameAddressID/FEIOperations
Process Technologies & Packaging, LLC809172885MANUFACTURE(61787-558)

Revised: 11/2013
 
Health Care Products

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide