Label: DERMAN ANTIFUNGAL- undecylenic acid spray

  • NDC Code(s): 54312-325-05
  • 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 10%

    Purpose

    Antifungal

  • Uses

    For treatment of Athlete's Foot Relieves • itching • scaling • cracking • burning

  • Warnings

    For external use only Avoid contact with the eyes

    Do not use

    on children under 2 years of age unless directed by a doctor

    If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

    Keep out of the reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    Wash the affected area and dry thoroughly. Apply a few drops 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. 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 and nails.

  • Inactive ingredients

    ethyl alcohol, fd and c yellow no. 5

  • Package Labeling:

    Outer Label0Inner Label0

  • INGREDIENTS AND APPEARANCE
    DERMAN ANTIFUNGAL 
    undecylenic acid spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54312-325
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54312-325-051 in 1 PACKAGE10/21/2013
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00510/21/2013
    Labeler - 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(54312-325)
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