Label: DERMAN ANTIFUNGAL- zinc undecylenate, undecylenic acid powder

  • NDC Code(s): 54312-925-01
  • Packager: Compania Internacional de Comercio, S.A.P.I. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 28, 2023

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  • Drug Facts


  • Active ingredients

    Undecylenic acid 2%

    Zinc undecylenate 20%

    Purpose

    Antifungal

  • Uses

    • For the treatment of athlete's foot • Relieves • itching • scaling • cracking • burning

  • Warnings

    For external use only.

    Do not use

    on children under 12 years of age unless directed by a doctor.

    When using this product

    avoid contact with the eyes.

    Stop use and ask a doctor

    if irritation occurs or if there is no improvement within 4 weeks.

    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 athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
    • Use daily for 4 weeks.
    • If condition persists longer, consult a doctor.
    • This product is not effective on the scalp or nails.
  • Inactive ingredients

    Fragrance, Koalin, Talc, Zinc Stearate

  • Package Labeling:

    Label3

  • Derman Antifungal Powder, 80g (54312-925-01)

    Outer Package 03Inner Package 03

  • INGREDIENTS AND APPEARANCE
    DERMAN ANTIFUNGAL 
    zinc undecylenate, undecylenic acid powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54312-925
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID2 g  in 100 g
    ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N) ZINC UNDECYLENATE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    KAOLIN (UNII: 24H4NWX5CO)  
    TALC (UNII: 7SEV7J4R1U)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54312-925-011 in 1 PACKAGE12/26/2017
    180 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00509/30/2013
    Labeler - Compania Internacional de Comercio, S.A.P.I. de C.V. (822165213)
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