Label: PINCELADAS PARA HONGOS NAVARRO- 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 February 18, 2022

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  • Active ingredient

    Undecylenic Acid 20%.................Antifungal

  • Purpose

    Antifungal

  • Uses

    • For the treatment of most athelete's foot, jock itch and ringworm
    • For relief if itching, scaling, cracking, burning, redness, soreness, irritations, discomfort, chafing associated with jock itch
    • For the relief of itch, scaly skin between toes
    • Clears up most athelete's foot infection and with daily use helps keep it from comming back
  • 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.
    • for diaper rash
  • Stop use and ask doctor if

    • For athelete's foot and ringworm, irritation occurs or if there is no improvement within 4 weeks.
    • For jock itch, if irritation occurs or if there is no improvement within 2 weeks.
  • If pregnant or breast-feeding,

    ask health professional before use. 

  • Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • Directions

    Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in use of this product. For athelete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athelete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

  • Other information

    • Protect from freezing. If freezing occurs, warm to room temperature 70°-80° F.
    • TAMPER EVIDENT DISCLOSURE: Do not use if seal is torn, broken or missing.
  • Inactive ingredients

    • isopropyl alcohol 99%, water
  • PRINCIPAL DISPLAY PANEL

    Pinceladas para hongo Navarro

  • INGREDIENTS AND APPEARANCE
    PINCELADAS PARA HONGOS NAVARRO 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-119-011 in 1 CARTON02/21/2012
    130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/21/2012
    Labeler - Menper Distributors, Inc. (101947166)
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