Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID f647308a-ea6c-47a9-a124-60e7888afac2
Route
TOPICAL
Published
Effective Date 2019-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (2 mg)
Inactive Ingredients
Hypromellose 2208 (100 Mpa.s) Aloe Vera Leaf Isopropyl Alcohol .alpha.-tocopherol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-07-01

Description

Active Ingredient                 Purpose Undecylenic Acid 20% w/v.......... Antifungal


Medication Information

Warnings and Precautions

For external use only.

Flammable: Keep away from fire and flame

When using this product

  • avoid contact with the eyes and mucous membrane.

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 Spray 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 and nails.

Description

Active Ingredient                 Purpose Undecylenic Acid 20% w/v.......... Antifungal

Section 50565-1

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



Section 50570-1

Stop use and consult a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Do not use

  • on children under 2 years of age unless directed by a doctor.
Section 51727-6

Inactive ingredients aloe vera, fragrance, hypromelloses, isopropyl alcohol, tocopherol acetate (vitamin E), water

Section 51945-4

Section 53413-1

Questions or Comments?

(305) 805-3456 Monday-Friday (9 am - 5 pm EST).

www.efficientlabs.com

Section 53414-9

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

Section 55105-1

Purpose: Antifungal

Section 55106-9

Active Ingredient                 Purpose

Undecylenic Acid 20% 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 Spray 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 and nails.

Warnings and Precautions (34071-1)

For external use only.

Flammable: Keep away from fire and flame

When using this product

  • avoid contact with the eyes and mucous membrane.

Section 50565-1 (50565-1)

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



Section 50570-1 (50570-1)

Stop use and consult a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Do not use

  • on children under 2 years of age unless directed by a doctor.
Section 51727-6 (51727-6)

Inactive ingredients aloe vera, 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 Monday-Friday (9 am - 5 pm EST).

www.efficientlabs.com

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose: Antifungal

Section 55106-9 (55106-9)

Active Ingredient                 Purpose

Undecylenic Acid 20% w/v.......... Antifungal


Advanced Ingredient Data


Raw Label Data

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