Update-85398-003-01

Update-85398-003-01
SPL v2
SPL
SPL Set ID 33612382-2f12-e9f6-e063-6394a90aaee4
Route
TOPICAL
Published
Effective Date 2025-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Stearic Acid Sodium Dodecylbenzenesulfonate Water Sorbitol Propylene Glycol Cocos Nucifera (coconut) Oil Lauric Acid Myristic Acid Sodium Hydroxide Sulfur Elaeis Guineensis (palm) Oil Olea Europaea (olive) Fruit Oil Sodium Glutamate Melaleuca Alternifolia (tea Tree) Leaf Oil Hamamelis Virginiana Root Bark/stem Bark Sodium Myristate Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-12

Description

coltrimazole 1%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Helps relieve and prevent itching, burning, cracking, and scaling associated with tinea versicolor infections.

Dosage and Administration
  • Wash the affected area thoroughly and allow the product to sit for 1-2 minutes before rinsing.
  • Ensure the affected area is dried completely.
  • Apply 1-2 times daily for 4 weeks.
  • This product is not effective for use on the scalp or nails.

Description

coltrimazole 1%

Section 44425-7

Store at room temperature. Protect from excessive heat (above 104ºF / 40ºC)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 50566-9

Stop use and ask doctor if irritation occurs or if 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

Do not use on Children under 2 years of age unless directed by a doctor.

Section 51727-6

Melaleuca Alternifolia (Tea Tree) Leaf Oil, 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 Dodecylbenzenesulfonate, Sulfur, Hamamelis Virginiana Root Bark, Ceramide

Section 51945-4

Section 53413-1

visit us at www.hermonhealth.com

Section 55105-1

antifungal

Section 55106-9

coltrimazole 1%


Structured Label Content

Indications and Usage (34067-9)

Helps relieve and prevent itching, burning, cracking, and scaling associated with tinea versicolor infections.

Dosage and Administration (34068-7)
  • Wash the affected area thoroughly and allow the product to sit for 1-2 minutes before rinsing.
  • Ensure the affected area is dried completely.
  • Apply 1-2 times daily for 4 weeks.
  • This product is not effective for use on the scalp or nails.

Warnings and Precautions (34071-1)

For external use only

Section 44425-7 (44425-7)

Store at room temperature. Protect from excessive heat (above 104ºF / 40ºC)

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 50566-9 (50566-9)

Stop use and ask doctor if irritation occurs or if 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)

Do not use on Children under 2 years of age unless directed by a doctor.

Section 51727-6 (51727-6)

Melaleuca Alternifolia (Tea Tree) Leaf Oil, 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 Dodecylbenzenesulfonate, Sulfur, Hamamelis Virginiana Root Bark, Ceramide

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)

coltrimazole 1%


Advanced Ingredient Data


Raw Label Data

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