Label: HONGOCURA M- undecylenic acid spray

  • NDC Code(s): 53145-219-03
  • Packager: MENPER DISTRIBUTORS, INC.
  • 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 April 14, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient  Purpose

    Undecylenic Acid 20% v/v.................Antifungal

  • PURPOSE

    Purpose

    • Antifungal
  • WARNINGS

    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 doctor
    • for diaper rash

    Stop use and ask a doctor if 

    • Irritation occurs 
    • there is no improvement within 4 weeks

    When using this product 

    • Avoid contact with eyes and mucus membrane
  • INDICATIONS & USAGE

    Do not use on children

    • Under 2 years of age, unless directed by a doctor
    • for diaper rash

    Stop use and ask a doctor if

    • Irritation occurs
    • there is no improvement within 4 weeks
    When using this product
    • Avoid contact with eyes and mucus membrane
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, consult a doctor before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions 

    • clean the affected area and dry throughly
    • apply a thin layer of Hongocura M Antifungal Spray over the affected area twice daily (morning and night) or as directed by a doctor 
    • supervise children in use of this product
    • for athlete'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 athlete's foot and ringworm, use daily for 4 weeks. if condition persists longer, consult a doctor
    • this product is not effective on the scalp or nails
    • store between 15°-30°C(59°-86°F)
  • INACTIVE INGREDIENT

    Inactive Ingredients

    isopropyl alcohol and water.

  • QUESTIONS

    Questions: 1-800-560-5223 Monday - Friday (9 AM - 4 PM EST) www.menperdistributors.com

  • PRINCIPAL DISPLAY PANEL

    HongoMSpray

  • INGREDIENTS AND APPEARANCE
    HONGOCURA  M
    undecylenic acid spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-219
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID20 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-219-031 in 1 CARTON04/06/2020
    160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/06/2020
    Labeler - MENPER DISTRIBUTORS, INC. (101947166)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!