Label: MICOCILEN ANTIFUNGAL- undecylenic acid liquid

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

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 Label Information

Updated March 4, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Undecilenic Acid 25%

    Purpose

    Fungicida

  • Uses

    For the cure of most

    • ringworm (tinea corporis)
    • athletes foot (tinea pedis)
  • Warnings

    For external use only. If pregnant or breastfeeding consult a healthcare professional before use.

    Do not use on children under 12 years of age unless directed by a Doctor. Avoid contact with eyes.

    Use only as directed by a Doctor on persons with high sensitive skin.

  • 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
  • Other Information

    Keep Tightly closed when not in use. Store away from excessive heat and cold

  • Inactive Ingredients

    Tea Tree Oil, Isopropyl Alcohol

  • PRINCIPAL DISPLAY PANEL - 29.5 ml Vial Carton

    Arymar

    Micocilen

    Antifungal
    Liquid

    • Easy to Apply
    • Dries Quickly, Non-Oily
      Formula

    Net Cont. 1 Fl. Oz.
    (29.5 ml)

    Arymar

    Principal Display Panel - 29.5 ml Vial Carton
  • INGREDIENTS AND APPEARANCE
    MICOCILEN   ANTIFUNGAL
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70570-0199
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Undecylenic Acid (UNII: K3D86KJ24N) (Undecylenic Acid - UNII:K3D86KJ24N) Undecylenic Acid250 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Tea Tree Oil (UNII: VIF565UC2G)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70570-0199-11 in 1 CARTON03/01/2014
    129.5 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C03/01/2014
    Labeler - Arymar Inc. (021650273)
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