Update-85398-008-01

Update-85398-008-01
SPL v2
SPL
SPL Set ID 3b3aa69f-4e73-cabc-e063-6294a90ab65b
Route
TOPICAL
Published
Effective Date 2025-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Terbinafine (1 g) Tolnaftate
Inactive Ingredients
Potassium Alum Propylene Glycol Aloe Barbadensis Leaf Juice Allantoin Polysorbate 80 Dimethicone C12-15 Pareth-7 Isohexadecane Glycerin Ethylparaben Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Glyceryl Stearate Sodium Glutamate Sorbitol Hamamelis Virginiana Bark Sodium Dodecylbenzenesulfonate Cocos Nucifera (coconut) Oil Sodium Hydroxide Elaeis Guineensis (palm) Oil Water Sodium Myristate Sulfur Stearic Acid Melaleuca Alternifolia (tea Tree) Leaf Oil Myristic Acid Olea Europaea (olive) Fruit Oil Lauric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-20

Description

Tolnaftate 1% (Soap Bar) Terbinafine Hydrochloride 1% (Cream)


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Soap Bar

  • Helps relieve and prevent itching, burning, cracking, and scaling associated with fungal infections such as athlete's foot, jock itch, ringworm, and other skin irritations.

Cream

  • Cures most athlete's foot (tinea pedis)
  • Cures most jock itch (tinea cruris) and ringworm (tinea corporis)
  • Relieves itching, burning, cracking and scaling which accompany these conditions

Dosage and Administration

Soap Bar

  • Wash the affected area thoroughly
  • Allow Hermon Antifungal Soap to sit for 1-2 minutes before rinsing.
  • Dry the area completely after washing.

Cream

  • adults and children 12 years and over
  • use the tip of the cap to break the seal and open the tube
  • wash the affected skin with soap and water and dry completely before applying
  • for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
  • between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor
  • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
  • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor
  • wash hands after each use
  • children under 12 years: ask a doctor

Description

Tolnaftate 1% (Soap Bar) Terbinafine Hydrochloride 1% (Cream)

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor

  • If irritatioin occurs or there is no improvement within 2 weeks.

Section 50567-7

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Section 50570-1
  • on children under 2 years of age unless directed by a doctor
  • on nails and scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections

Section 51727-6

Soap Bar

Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aqua (Water), Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate, Sulfur Thermal Water, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide

Inactive ingredients



Cream

Allantoin, Glycerin, Propylene Glycol, PCA Dimethicone, Ethylparaben, Glyceryl Stearate, Primary Alcohol Ethoxylate, Alumen, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexade- cane, Polysorbate 80, Aloe Barbadensis Leaf Juice, Parfum

Section 51945-4

Section 53413-1

visit us at www.hermonhealth.com

Section 55105-1

antifungal

Section 55106-9

Tolnaftate 1% (Soap Bar)

Terbinafine Hydrochloride 1% (Cream)

Section 60561-8

Do not use if seal on tube is broken or is not visible. Store at room temperature. Protect from excessive heat (above 104°F / 40°C)


Structured Label Content

Indications and Usage (34067-9)

Soap Bar

  • Helps relieve and prevent itching, burning, cracking, and scaling associated with fungal infections such as athlete's foot, jock itch, ringworm, and other skin irritations.

Cream

  • Cures most athlete's foot (tinea pedis)
  • Cures most jock itch (tinea cruris) and ringworm (tinea corporis)
  • Relieves itching, burning, cracking and scaling which accompany these conditions

Dosage and Administration (34068-7)

Soap Bar

  • Wash the affected area thoroughly
  • Allow Hermon Antifungal Soap to sit for 1-2 minutes before rinsing.
  • Dry the area completely after washing.

Cream

  • adults and children 12 years and over
  • use the tip of the cap to break the seal and open the tube
  • wash the affected skin with soap and water and dry completely before applying
  • for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
  • between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor
  • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
  • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor
  • wash hands after each use
  • children under 12 years: ask a doctor

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor

  • If irritatioin occurs or there is no improvement within 2 weeks.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Section 50570-1 (50570-1)
  • on children under 2 years of age unless directed by a doctor
  • on nails and scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections

Section 51727-6 (51727-6)

Soap Bar

Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aqua (Water), Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate, Sulfur Thermal Water, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide

Inactive ingredients



Cream

Allantoin, Glycerin, Propylene Glycol, PCA Dimethicone, Ethylparaben, Glyceryl Stearate, Primary Alcohol Ethoxylate, Alumen, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexade- cane, Polysorbate 80, Aloe Barbadensis Leaf Juice, Parfum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

visit us at www.hermonhealth.com

Section 55105-1 (55105-1)

antifungal

Section 55106-9 (55106-9)

Tolnaftate 1% (Soap Bar)

Terbinafine Hydrochloride 1% (Cream)

Section 60561-8 (60561-8)

Do not use if seal on tube is broken or is not visible. Store at room temperature. Protect from excessive heat (above 104°F / 40°C)


Advanced Ingredient Data


Raw Label Data

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