HONGOCURA- undecylenic acid, zinc undecylenate ointment

Hongocura by

Drug Labeling and Warnings

Hongocura by is a Otc medication manufactured, distributed, or labeled by MENPER DISTRIBUTORS, INC., RNV, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients      Purpose

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

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

PURPOSE

Purpose Antifungal

INDICATIONS & USAGE

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.

WARNINGS

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 OUT OF REACH OF CHILDREN

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

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive ingredients: Methylparaben, propylparaben and white petrolatum

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HONGOCURA 
undecylenic acid, zinc undecylenate ointment

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	10/09/2018

Labeler - MENPER DISTRIBUTORS, INC. (101947166)

Establishment
Name	Address	ID/FEI	Business Operations
RNV, LLC		118917568	manufacture(53145-017)