MYCO NAIL A ANTIFUNGAL SOLUTION (UNDECYLENIC ACID) LIQUID [KRAMER NOVIS]

  • Home
  • MYCO NAIL A ANTIFUNGAL SOLUTION (UNDECYLENIC ACID) LIQUID [KRAMER NOVIS]

MYCO NAIL A ANTIFUNGAL SOLUTION (UNDECYLENIC ACID) LIQUID [KRAMER NOVIS]
PDF | XML
NDC 52083-242-30
Set ID 550358d7-69e8-4ea3-bcf9-d647c457287d
Category HUMAN OTC DRUG LABEL
Packager Kramer Novis
Generic Name
Product Class
Product Number
Application Number PART333C
View All Sections
  • 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 HYDRATE (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)
View All Sections

Related Drugs

Search DailyMed Drugs