Drug Facts

Drug Facts
SPL v12
SPL
SPL Set ID 5c433182-0c0c-4a0a-8dd8-a14f60e52425
Route
TOPICAL
Published
Effective Date 2019-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (25 mg)
Inactive Ingredients
Aloe Vera Leaf Hypromellose 2208 (100 Mpa.s) Isopropyl Alcohol Water .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-07-01

Description

Active Ingredient                                   Purpose Undecylenic Acid 25% w/v ............................. Antifungal


Medication Information

Warnings and Precautions

Warnings

For external use only

Flammable: Keep away from fire or flame.

When using this product:avoid with eyes or mucous membrane.

Stop use and ask a doctor if:



  • irritation occurs
  • there is no improvement within 4 weeks
Indications and Usage

Uses

For the cure of most:

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

For the relief of:

  • itching
  • burning
  • scaling
  • cracking
  • soreness
  • irritation
Dosage and Administration

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 the scalp or nails.
Description

Active Ingredient                                   Purpose Undecylenic Acid 25% w/v ............................. Antifungal

Section 50565-1

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

Section 50570-1

Do not use on children under 2 years of age unless directed by a doctor.

Section 51727-6

Inactive ingredients

aloe, fragrance, hypromelloses, isopropyl alcohol, tocopherol acetate (Vitamin E), water

Section 51945-4

Section 53413-1

Questions or comments?

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

Section 53414-9

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

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active Ingredient                                   Purpose

Undecylenic Acid 25% w/v ............................. Antifungal


Structured Label Content

Indications and Usage (34067-9)

Uses

For the cure of most:

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

For the relief of:

  • itching
  • burning
  • scaling
  • cracking
  • soreness
  • irritation
Dosage and Administration (34068-7)

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 the scalp or nails.
Warnings and Precautions (34071-1)

Warnings

For external use only

Flammable: Keep away from fire or flame.

When using this product:avoid with eyes or mucous membrane.

Stop use and ask a doctor if:



  • irritation occurs
  • there is no improvement within 4 weeks
Section 50565-1 (50565-1)

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

Section 50570-1 (50570-1)

Do not use on children under 2 years of age unless directed by a doctor.

Section 51727-6 (51727-6)

Inactive ingredients

aloe, fragrance, hypromelloses, isopropyl alcohol, tocopherol acetate (Vitamin E), water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active Ingredient                                   Purpose

Undecylenic Acid 25% w/v ............................. Antifungal


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)