Initial Drug Listing - Hermon Antifungal Jock Itch Body Wash

Initial Drug Listing - Hermon Antifungal Jock Itch Body Wash
SPL v1
SPL
SPL Set ID 409ef5c0-dfe5-f26a-e063-6294a90a2745
Route
TOPICAL
Published
Effective Date 2025-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (5 g)
Inactive Ingredients
Hamamelis Virginiana (witch Hazel) Leaf Water Aloe Barbadensis Leaf Juice Trehalose Hydrolyzed Soy Protein (enzymatic; 2000 Mw) Sodium Chloride Cocamidopropyl Betaine Aqua Melaleuca Alternifolia (tea Tree) Leaf Oil Cocamide Methyl Mea Panthenol Sodium Hyaluronate Sodium Lauroyl Sarcosinate Phenoxyethanol Calcium Disodium Edta Glycerin Arginine Citric Acid Allantoin Disodium Cocoyl Glutamate Lactobacillus Sodium Benzoate Mentha Arvensis Leaf Menthol Lauryl Glucoside Sodium Lauroamphoacetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-31

Description

Tolnaftate 1%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • Use daily in the shower or bath
  • Apply to affected area and surrounding skin
  • Lather and leave on skin for 1-2 minutes, thenrinse thoroughly
  • Dry affected area completely
  • For jock itch and ringworm, use twice daily for 2 weeks
  • For athlete's foot, use twice daily for 4 weeks
  • To help prevent recurrence, continue use after symptoms disappear or as directed by a doctor
Dosage and Administration
  • Treats most jock itch, athlete's foot, and ringworm
  • Relieves itching, burning, cracking,and discomfort associated with fungal infections
  • Helps prevent recurrence of jock itch and athlete's foot with daily use
Description

Tolnaftate 1%

Section 50565-1

If swallowed, get medical help or contact aPoison Control Center right away.

Section 50567-7
  • Avoid contact with eyes. lf contact occurs, rinse thoroughly with water
  • Do not use onbroken or severely irritated skin
  • Do not apply over large areas of the body
Section 50569-3
  • lrritation occurs
  • No improvement is seen within 2 weeks (for jock itch and ringworm)
  • No improvement is seen within 4 weeks (for athlete's foot)
Section 51727-6

Aqua, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betaine, Lauryl Glucoside, Sodium Lauroamphoacetate, Cocamide Methyl MEA,Disodium Cocoyl Glutamate, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Chloride,Trehalose, Phenoxyethanol, Panthenol, Hamamelis virginiana (Witch Hazel) Water, Aloe Barbadensis Leaf Extract, Sodium Benzoate,Menthol, Arginine, Mentha Arvensis Leaf Extract, Lactobacillus/Rice Ferment, Hydrolyzed OatProtein, Allantoin, Citric Acid, Disodium EDTA,Hydrolyzed Sodium Hyaluronate.

Section 51945-4

Section 53413-1
Section 55105-1

Antifungal

Section 55106-9

Tolnaftate 1%

Section 60561-8

Store at 15°-30°C(59°-86°F)

Do not use if seal under cap is broken or missing


Structured Label Content

Indications and Usage (34067-9)
  • Use daily in the shower or bath
  • Apply to affected area and surrounding skin
  • Lather and leave on skin for 1-2 minutes, thenrinse thoroughly
  • Dry affected area completely
  • For jock itch and ringworm, use twice daily for 2 weeks
  • For athlete's foot, use twice daily for 4 weeks
  • To help prevent recurrence, continue use after symptoms disappear or as directed by a doctor
Dosage and Administration (34068-7)
  • Treats most jock itch, athlete's foot, and ringworm
  • Relieves itching, burning, cracking,and discomfort associated with fungal infections
  • Helps prevent recurrence of jock itch and athlete's foot with daily use
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

If swallowed, get medical help or contact aPoison Control Center right away.

Section 50567-7 (50567-7)
  • Avoid contact with eyes. lf contact occurs, rinse thoroughly with water
  • Do not use onbroken or severely irritated skin
  • Do not apply over large areas of the body
Section 50569-3 (50569-3)
  • lrritation occurs
  • No improvement is seen within 2 weeks (for jock itch and ringworm)
  • No improvement is seen within 4 weeks (for athlete's foot)
Section 51727-6 (51727-6)

Aqua, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betaine, Lauryl Glucoside, Sodium Lauroamphoacetate, Cocamide Methyl MEA,Disodium Cocoyl Glutamate, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Chloride,Trehalose, Phenoxyethanol, Panthenol, Hamamelis virginiana (Witch Hazel) Water, Aloe Barbadensis Leaf Extract, Sodium Benzoate,Menthol, Arginine, Mentha Arvensis Leaf Extract, Lactobacillus/Rice Ferment, Hydrolyzed OatProtein, Allantoin, Citric Acid, Disodium EDTA,Hydrolyzed Sodium Hyaluronate.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)
Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Tolnaftate 1%

Section 60561-8 (60561-8)

Store at 15°-30°C(59°-86°F)

Do not use if seal under cap is broken or missing


Advanced Ingredient Data


Raw Label Data

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