HONGOCURA- undecylenic acid, zinc undecylenate ointment 
MENPER DISTRIBUTORS, INC.

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.

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Active Ingredients      Purpose

Undecylenic Acid 5%...................Antifungal

Zinc Undecylenate 20%...............Antifungal

Purpose Antifungal

Uses:

Proven effective in the treatment of athlete's foot (tinea pedis),jock itch (tinea cruris) and ringworm (tinea corporis).
For the effective relief of itching, burning, crackling and scaly skin between toes.

Clears up athlete's foot infection and with daily use, helps keep it from coming back.

Warning: 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. This product is not effective on the scalp or nails.

Stop use and ask a doctor if: For athlete's foot and ringworm, if irritation occurs or if there is no improvement within 4 weeks. For jock itch, if irritation occurs or if there is no improvment within 2 weeks

Keep away of reach of children. In case of accidental ingestion, get medical help or contact a Posion Control Center, right away.

If pregnant or breast-feeding, ask a health professional before use.

Directions:

Clean the affected area and dry throughly. 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 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. For jock itch, use daily for 2 weeks, if condition persists longer, consult a doctor. This product is not effective for the scalp or nails.

Inactive ingredients: Methylparaben, propylparaben and white petrolatum

Questions? www.menperdistributors.com or 1-800-560-5223, M-F 9 am- 4 pm EST

Hongocura Ointment

HONGOCURA 
undecylenic acid, zinc undecylenate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID5 g  in 100 g
ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N) ZINC UNDECYLENATE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53145-017-281 in 1 CARTON10/09/2018
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/09/2018
Labeler - MENPER DISTRIBUTORS, INC. (101947166)

Revised: 4/2021
 
MENPER DISTRIBUTORS, INC.