Label: MICOCILEN- undecylenic acid cream

  • 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

    Undecylenic Acid 15%

  • Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of most athletes foot (linea pedis) and ringworm (linea corporis)
  • Warnings

    • For external use only

    If pregnant or breast feeding consult a healthcare professional before use

    Do not use on children under 2 years of age except under advice and supervision of a doctor

    Use only as directed by a doctor on persons with highly sensitive skin

    When using this product avoid contact with the eyes

    Stop use and ask a doctor if

    • irritation occurs
    • 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 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

    Purified Water, Cetyl Alcohol, Acrylate/Sodium Acryloyl Dimethyl Taurate Copolymer, Glycerl Monostearate, Caprylic Triglyceride, Polysorbate 20, Phenol, Salicylic Acid, Tea Tree Oil.

  • SPL UNCLASSIFIED SECTION

    Distributed by: Arymar Inc.
    8004 NW 154 St. #343 Miami Lakes FL 33016

  • PRINCIPAL DISPLAY PANEL - 29.5 ml Tube Carton

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

    Micocilen

    Antifungal
    Cream

    Cures & Prevents Most Athlete's Foot
    Relieves Itching and Burning

    Net Cont. 1 Fl. Oz (29.5 ml)

    PRINCIPAL DISPLAY PANEL - 29.5 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    MICOCILEN 
    undecylenic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70570-0198
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Undecylenic Acid (UNII: K3D86KJ24N) (Undecylenic Acid - UNII:K3D86KJ24N) Undecylenic Acid150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Tricaprylin (UNII: 6P92858988)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Phenol (UNII: 339NCG44TV)  
    Salicylic Acid (UNII: O414PZ4LPZ)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70570-0198-11 in 1 CARTON02/01/2015
    129.5 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C02/01/2015
    Labeler - Arymar Inc. (021650273)
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