Label: DERMAN ANTIFUNGAL- zinc undecylenate cream

  • NDC Code(s): 54312-125-01, 54312-125-02
  • 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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  • SPL UNCLASSIFIED SECTION

  • SPL UNCLASSIFIED SECTION

  • Active Ingredients.

    Zinc undecylenate  18%

    Undecylenic acid    5%

    Purpose

    Antifungal

  • Uses

    For the treatment of athlete´s foot.

  • Warnings

    For external use only

    Do not use

    on children under 2 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 the 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 the 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, consults a physician. 
    • This product is not effective on the scalp or nails.
  • Inactive ingredients

    Cetyl alcohol, Glycerin, Polyethylene Glycol 500, Polyethylene glycol 4000, Propylene glycol, Sodium bisulfite, Sodium laureth sulfate, water, Zinc stearate.

  • Derman Antifungal (54312-125-01)

    LabelLabel2Label3Label4

  • Derman Antifungal (54312-125-02)

    Outer Package3Inner Package3Outer Package4Inner Package4

  • INGREDIENTS AND APPEARANCE
    DERMAN ANTIFUNGAL 
    zinc undecylenate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54312-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID5 g  in 100 g
    ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N) ZINC UNDECYLENATE18 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BISULFITE (UNII: TZX5469Z6I)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54312-125-011 in 1 CARTON08/12/2013
    125 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:54312-125-021 in 1 CARTON08/12/2013
    250 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00508/12/2013
    Labeler - Compania Internacional de Comercio, S.A.P.I de C.V. (822165213)
    Registrant - Compania Internacional de Comercio, S.A.P.I de C.V. (822165213)
    Establishment
    NameAddressID/FEIBusiness Operations
    Compania Internacional de Comercio, S.A.P.I de C.V.822165213manufacture(54312-125)
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