Update-85398-011-01

Update-85398-011-01
SPL v2
SPL
SPL Set ID 3cdcf8cc-510c-6115-e063-6294a90ac3ea
Route
TOPICAL
Published
Effective Date 2025-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1.16 g)
Inactive Ingredients
Cocos Nucifera (coconut) Oil Propylene Glycol Lauric Acid Myristic Acid Sodium Myristate Sodium Dodecylbenzenesulfonate Ceramide 1 Sorbitol Elaeis Guineensis (palm) Oil Olea Europaea (olive) Fruit Oil Stearic Acid Melaleuca Alternifolia (tea Tree) Leaf Oil Glycerin Aqua Sodium Glutamate Sodium Hydroxide Hamamelis Virginiana (witch Hazel) Leaf Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-31

Description

Clotrimazole 1%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • Wet skin with warm water and lather soap.
  • Gently massage onto affected areas.
  • Rinse thoroughly and dry.
  • Use twice daily or as directed by a doctor.
Dosage and Administration

Proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tineacorporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.

Description

Clotrimazole 1%

Section 44425-7

Store at room temperature. Protect from excessive heat (above 104°F/40°C)

Section 50565-1

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

Section 50566-9

irritation occurs or if there is no improvement within 2 weeks.

Section 50567-7

avoide contact with eyes, lf contact occurs, rinse thoroughly with water.

Section 50570-1

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

Section 51727-6

Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aqua (Water), Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil.Olea Europaea (0live) Fruit Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hvdroxide, Sodium Dodecylbenzene Sulfonate, Sulfur Thermal Water, Hamamelis Virginiana (WitchHazel) Extract, Ceramide

Section 51945-4

Section 53413-1

visit us at www.hermonhealth.com

Section 55105-1

Antifungal

Section 55106-9

Clotrimazole 1%


Structured Label Content

Indications and Usage (34067-9)
  • Wet skin with warm water and lather soap.
  • Gently massage onto affected areas.
  • Rinse thoroughly and dry.
  • Use twice daily or as directed by a doctor.
Dosage and Administration (34068-7)

Proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tineacorporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.

Warnings and Precautions (34071-1)

For external use only

Section 44425-7 (44425-7)

Store at room temperature. Protect from excessive heat (above 104°F/40°C)

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

irritation occurs or if there is no improvement within 2 weeks.

Section 50567-7 (50567-7)

avoide contact with eyes, lf contact occurs, rinse thoroughly with water.

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aqua (Water), Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil.Olea Europaea (0live) Fruit Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hvdroxide, Sodium Dodecylbenzene Sulfonate, Sulfur Thermal Water, Hamamelis Virginiana (WitchHazel) Extract, 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)

Clotrimazole 1%


Advanced Ingredient Data


Raw Label Data

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