HONGO KILLER NAIL AND FUNGUS- undecylenic acid kit

Hongo Killer by

Drug Labeling and Warnings

Hongo Killer by is a Otc medication manufactured, distributed, or labeled by EFFICIENT LABORATORIES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Undecylenic Acid 25%

Purpose

Antifungal

Uses

For the cure of most:

• athlete's foot (tinea pedis)
• ringworm (tinea corporis)

For the relief of:

• itching
• burning
• scaling
• cracking
• soreness
• irritation

Warnings

For external use only

Flammable: Keep away from fire or flame.

When using this product: avoid contact with eyes or mucous membranes.

Stop use and ask doctor if:

• irritation occurs
• there is no improvement within 4 weeks

Do not use on children under 2 years of age

Pregnancy or Breast Feeding

If pregnant or breast-feeding, consult a health care professional before using this product

Keep out of Reach of Children

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

Directions

Clean the affected area and dry thoroughly

• Apply a thin layer of Hongo Killer Antifungal Solution over affected area twice daily (morning and night) or as directed by a doctor
• Supervise children in the use of this product.
• For athlete's foot: Pay special attention to spaces between 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 scalp or nails.

Questions

Questions or comments?

305-805-3456 (M-F 9:00 am - 5:00 pm EST) www.efficientlabs.com

Inactive ingredients

aloe vera, fragrance, hydroxypropyl methylcellulose, isopropyl alcohol (70% v/v), water, Vitamin E

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HONGO KILLER  NAIL AND FUNGUS
undecylenic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58593-301

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58593-301-60	1 in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package	07/01/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, WITH APPLICATOR	30 mL
Part 2	1 PACKAGE	30 mL

Part 1 of 2

HONGO KILLER 
undecylenic acid liquid

Product Information
Item Code (Source)	NDC: 58593-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58593-300-01	30 mL in 1 BOTTLE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C

Part 2 of 2

HONGO KILLER NAIL 
nail creams and lotions

Product Information

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 PACKAGE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333c	07/01/2016

Labeler - EFFICIENT LABORATORIES INC (969044932)