Label: MYCO NAIL A ANTIFUNGAL SOLUTION- 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 October 31, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Undecylenic Acid 25% v/v

  • Purpose

    Antifungal

  • Uses

    For the treatment of athlete's foot (tinea pedis), ringworm (tinea corporis). For effective relief of itching, irritation, and burning feet.

  • Warnings

    For external use only. Flammable: Keep away from fire and flame.

    Do not use on children under 2 years of age unless directed by a physician.

    When using this product avoid contact with the eyes and mucuos membranes.

    Stop use and ask a doctor if irritation occurs or is 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. If you are pregnant or breast-feeding consult a health care professional before using this product.

  • Directions

    Clean the affected area and dry thoroughly. Apply a thin layer of Myco Nail A over the affected area twice daily (morning and night) or as directed by a physician. Supervise children in the use of this product. For athlete's foot: pay special attention to spaces between toes; wear well-fitted, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer, consult a physcian.

  • Other information

    Store between 15 - 30 C (50 – 86F).

    Do not accept if safety seal is broken or missing.

  • Inactive ingredients

    Benzyl acetate, benzyl alcohol, cetylpyridinium chloride, chloroxylenol, eucalyptol, glacial acetic acid, Isopropyl alcohol, propionic acid, propylene glycol, sodium propionate and triacetin.

  • Questions or omments:

    Kramer Novis, San Juan PR, 1-787-767-2072

  • PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton

    Myco Nail A®

    Antifungal Solution

    Topical Formula

    1 Fl. Oz. 30 ml.

    MANUFACTURED IN USA FOR

    KRAMER-NOVIS

    San Juan, P.R. 00918

    PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    MYCO NAIL A ANTIFUNGAL SOLUTION 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-242
    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
    BENZYL ACETATE (UNII: 0ECG3V79ZJ)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPIONIC ACID (UNII: JHU490RVYR)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PROPIONATE (UNII: DK6Y9P42IN)  
    TRIACETIN (UNII: XHX3C3X673)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-242-301 in 1 CARTON01/14/2014
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C01/14/2014
    Labeler - Kramer Novis (090158395)
    Registrant - Kramer Novis (090158395)
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