Initial Drug Listing - Hermon Antifungal Stick

Initial Drug Listing - Hermon Antifungal Stick
SPL v1
SPL
SPL Set ID 474a5783-4488-034e-e063-6294a90a5de3
Route
TOPICAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (0.4 g)
Inactive Ingredients
Butylene Glycol Aloe Phenoxyethanol Stearyl Alcohol Kaolin Sodium Benzoate Cetyl Alcohol Propylene Glycol Glycerin Hydrogenated Castor Oil Zinc Oxide Talc Menthol, (+)- Melaleuca Alternifolia (tea Tree) Leaf Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-15

Description

Clotrimazole 1%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage
  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of this product over affected area twice daily(morning and night).
  • Use daily for 2weeks for jock itch, 4 weeks for athlete'sfoot and ringworm.
  • Supervise childrenin the use of this product.

For athlete's foot:

Pay special attentionto the spaces between toes; wearwell-fitting, ventilated shoes and change shoes and socks at least once daily

Dosage and Administration
  • For the treatment of most athlete's foot (tinea pedis), jock itch (tineacruris), and ringworm (tinea corporis)
  • Relieves itching, burning, cracking,scaling and discomfort associated with these conditions
Description

Clotrimazole 1%

Section 50565-1

lf swallowed,get medical help or contact a Poison Control Center right away.

Section 50566-9

if irritation occurs or if there is no improvement within 4 weeks(for athlete's foot and ringworm) or within 2 weeks (for jock itch).

Section 50567-7

avoid contact with eyes.

Section 50570-1

on children under 2 years of age unless directed by a doctor.

Section 51727-6

Propylene Glycol, Stearyl Alcohol, Cetyl Alcohol, Butylene Glycol, Glycerin,Hydrogenated Castor Oil, Talc, Zinc Oxide,Kaolin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Yohjyu Matsu Ekisu, Menthol,Sodium Benzoate, Phenoxyethanol

Section 51945-4

Section 53413-1
Section 55105-1

Antifungal

Section 55106-9

Clotrimazole 1%

Section 60561-8

Store at room temperature.Keep cap tightly closed when not in use


Structured Label Content

Indications and Usage (34067-9)
  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of this product over affected area twice daily(morning and night).
  • Use daily for 2weeks for jock itch, 4 weeks for athlete'sfoot and ringworm.
  • Supervise childrenin the use of this product.

For athlete's foot:

Pay special attentionto the spaces between toes; wearwell-fitting, ventilated shoes and change shoes and socks at least once daily

Dosage and Administration (34068-7)
  • For the treatment of most athlete's foot (tinea pedis), jock itch (tineacruris), and ringworm (tinea corporis)
  • Relieves itching, burning, cracking,scaling and discomfort associated with these conditions
Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

lf swallowed,get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

if irritation occurs or if there is no improvement within 4 weeks(for athlete's foot and ringworm) or within 2 weeks (for jock itch).

Section 50567-7 (50567-7)

avoid contact with eyes.

Section 50570-1 (50570-1)

on children under 2 years of age unless directed by a doctor.

Section 51727-6 (51727-6)

Propylene Glycol, Stearyl Alcohol, Cetyl Alcohol, Butylene Glycol, Glycerin,Hydrogenated Castor Oil, Talc, Zinc Oxide,Kaolin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Yohjyu Matsu Ekisu, Menthol,Sodium Benzoate, Phenoxyethanol

Section 51945-4 (51945-4)

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

Antifungal

Section 55106-9 (55106-9)

Clotrimazole 1%

Section 60561-8 (60561-8)

Store at room temperature.Keep cap tightly closed when not in use


Advanced Ingredient Data


Raw Label Data

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