Label: DIABETIDERM ANTIFUNGAL- undecylenic acid cream 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/13

If you are a consumer or patient please visit this version.

  • Active ingredient

    Undecylenic Acid 10%

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  • Purpose

    Antifungal

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  • Uses

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

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  • 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
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  • Other information

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

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  • 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

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  • 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)

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  • INGREDIENTS AND APPEARANCE
    DIABETIDERM ANTIFUNGAL 
    undecylenic acid cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL 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 WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61787-481-15 1 in 1 CARTON
    1 42 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 07/01/2007 12/31/2014
    Labeler - Health Care Products (101196749)
    Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
    Establishment
    Name Address ID/FEI Business Operations
    Process Technologies & Packaging, LLC 809172885 MANUFACTURE(61787-481)
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