Drug Facts

Drug Facts
SPL v18
SPL
SPL Set ID 8c9c958a-2371-4ce5-948e-625c26cdaacb
Route
TOPICAL
Published
Effective Date 2020-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Starch, Corn Methylparaben Propylparaben Sodium Bicarbonate Talc Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2000-01-01 Until 2015-10-15

Description

Active Ingredients:             Purpose Tolnaftate 1% W/W........................ Antifungal


Medication Information

Warnings and Precautions

Warnings

For external use only. Avoid contact with eyes.

Indications and Usage

Uses

For effective treatment of:

  • athlete's foot (tinea pedis)
  • jock itch (Tinea Cruris)
  • ringworm (tinea corporis)

For the relief of itching, burning feet.

For the prevention of athlete's foot with daily use

Dosage and Administration

Directions

  • clean the affected area and dry thoroughly
  • Sprinkle Hongo Killer powder liberally over the affected area twice daily (morning and night) or as direct by doctor
  • 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 prodcut is not effective on scalp or nails.
  • Supervise children in the use of Hongo Killer
Description

Active Ingredients:             Purpose Tolnaftate 1% W/W........................ Antifungal

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding consult a health professional before use.

Section 50570-1

Do not use on children under 2 years of age

Stop use and ask a doctor if irritation occurs or if there's no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks for jock itch.

Section 51727-6

Inactive ingredients Corn (Zea Mays) Starch, Methylparaben, Propylparaben, Sodium Bicardbonate, Talc and Zinc Oxide.

Section 51945-4

Section 53413-1

Questions or comments?

www.efficientlabs.com

Please Call 305-805-3456 (M-F 9:00-5:00 pm EST)

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active Ingredients:             Purpose

Tolnaftate 1% W/W........................ Antifungal






Structured Label Content

Indications and Usage (34067-9)

Uses

For effective treatment of:

  • athlete's foot (tinea pedis)
  • jock itch (Tinea Cruris)
  • ringworm (tinea corporis)

For the relief of itching, burning feet.

For the prevention of athlete's foot with daily use

Dosage and Administration (34068-7)

Directions

  • clean the affected area and dry thoroughly
  • Sprinkle Hongo Killer powder liberally over the affected area twice daily (morning and night) or as direct by doctor
  • 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 prodcut is not effective on scalp or nails.
  • Supervise children in the use of Hongo Killer
Warnings and Precautions (34071-1)

Warnings

For external use only. Avoid contact with eyes.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding consult a health professional before use.

Section 50570-1 (50570-1)

Do not use on children under 2 years of age

Stop use and ask a doctor if irritation occurs or if there's no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks for jock itch.

Section 51727-6 (51727-6)

Inactive ingredients Corn (Zea Mays) Starch, Methylparaben, Propylparaben, Sodium Bicardbonate, Talc and Zinc Oxide.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

www.efficientlabs.com

Please Call 305-805-3456 (M-F 9:00-5:00 pm EST)

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active Ingredients:             Purpose

Tolnaftate 1% W/W........................ Antifungal






Advanced Ingredient Data


Raw Label Data

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