Label: HONGO KILLER NAIL AND FUNGUS- undecylenic acid kit
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- NDC Code(s): 58593-300-01, 58593-301-60
- Packager: EFFICIENT LABORATORIES 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 February 15, 2020
If you are a consumer or patient please visit this version.
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- Active Ingredients
- Purpose
- Uses
- Warnings
- Pregnancy or Breast Feeding
- Keep out of Reach of Children
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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.
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- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HONGO KILLER NAIL AND FUNGUS
undecylenic acid kitProduct 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 liquidProduct 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 lotionsProduct 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)
