Update-85398-012-01

Update-85398-012-01
SPL v2
SPL
SPL Set ID 3ceec52e-4089-9eb0-e063-6294a90ad52a
Route
TOPICAL
Published
Effective Date 2025-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (0.57 g)
Inactive Ingredients
Edetate Disodium Ethylparaben Water Butylated Hydroxytoluene Glycerol Formal White Petrolatum Mineral Oil Cetostearyl Alcohol Dimethyl Sulfoxide Alcohol Myristic Acid Sodium Myristate Sodium Hydroxide Elaeis Guineensis (palm) Oil Propylene Glycol Lauric Acid Hamamelis Virginiana (witch Hazel) Leaf Water Sodium Dodecylbenzenesulfonate Aqua Sodium Glutamate Melaleuca Alternifolia (tea Tree) Leaf Oil Stearic Acid Sorbitol Olea Europaea (olive) Fruit Oil Glycerin Cocos Nucifera (coconut) Oil Ceramide 1

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

For cream

  • Wash affected area & dry thoroughly.
  • Apply a thin layer over affected area twice dally (morning andnight).
  • Supervise children in the use of this product.
  • Use daily for 2 weeks.

For soap

  • 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

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

Section 50567-7

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

Section 50569-3

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

Section 50570-1

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

Section 51727-6

For cream:

Purifed Water, White Petrolatum, Mineral Oil, Glycerol, Cetostearyl Alcohol, Glyceryl Mono-And Distearate, Dimethyl sulfoxide, Alcohol, Polyoxyethylene Lauryl Ether (Peregal 0), Edetate Disodium, Butylated Hydroxytoluene, Ethylparaben

For soap:

Melaleuca Alternifalla (Tea Tree) Leaf Oil, Aqua (Water), Sorbitol, Elaeis Guineensis (Palm) Olil, Cocos Nucifera (Coconut) Olil,Olea Europaea (0live) Fruit Oi, Propylene Glycol, Glycerin, stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, 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)

For cream

  • Wash affected area & dry thoroughly.
  • Apply a thin layer over affected area twice dally (morning andnight).
  • Supervise children in the use of this product.
  • Use daily for 2 weeks.

For soap

  • 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)

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

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

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

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)

For cream:

Purifed Water, White Petrolatum, Mineral Oil, Glycerol, Cetostearyl Alcohol, Glyceryl Mono-And Distearate, Dimethyl sulfoxide, Alcohol, Polyoxyethylene Lauryl Ether (Peregal 0), Edetate Disodium, Butylated Hydroxytoluene, Ethylparaben

For soap:

Melaleuca Alternifalla (Tea Tree) Leaf Oil, Aqua (Water), Sorbitol, Elaeis Guineensis (Palm) Olil, Cocos Nucifera (Coconut) Olil,Olea Europaea (0live) Fruit Oi, Propylene Glycol, Glycerin, stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, 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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:53.080948 · Updated: 2026-03-14T23:14:02.652954