Hongocura by MENPER DISTRIBUTORS, INC.

Drug Details [pdf]

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-017
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	5 g in 100 g
ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	ZINC UNDECYLENATE	20 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 53145-017-28	1 in 1 CARTON	10/09/2018
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	10/09/2018

Labeler - MENPER DISTRIBUTORS, INC. (101947166)

Revised: 4/2021

Document Id: 22fcadf6-676b-43c7-afdc-a3d3957ab77c

Set id: c69b735e-0ffe-4328-bd9f-3c1ac6798c08

Version: 1

Effective Time: 20210414

Trademark Results [Hongocura]

Mark Image Registration \| Serial	Company Trademark Application Date
HONGOCURA 85361067 not registered Dead/Abandoned	Menper Distributors, Inc. 2011-06-30