Update-85398-010-01

Update-85398-010-01
SPL v2
SPL
SPL Set ID 3c9bd942-49c6-cada-e063-6394a90a3166
Route
TOPICAL
Published
Effective Date 2025-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (0.57 g)
Inactive Ingredients
Butylated Hydroxytoluene Glycerol Formal Alcohol White Petrolatum Cetostearyl Alcohol Edetate Disodium Dimethyl Sulfoxide Ethylparaben Water Mineral Oil

Identifiers & Packaging

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

Cotrimazole 1%

Medication Information

Warnings and Precautions

For external use only.

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

Cotrimazole 1%

Section 44425-7

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

Section 50565-1

in case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

(1-800-222-1222)

Section 50567-7

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

Section 50569-3

if 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

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

Section 51945-4

Section 53413-1

visit us at www.hermonhealth.com

Section 55105-1

Antifungal

Section 55106-9

Cotrimazole 1%

Structured Label Content

Indications and Usage (34067-9)
  • Wash affected area & dry thoroughly.
  • Apply a thin layer over affected area twice daily (morning andnight).
  • Supervise children in the use of this product.
  • Use daily for 2 weeks.
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)

in case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

(1-800-222-1222)

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

if 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)

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

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)

Cotrimazole 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:53.073193 · Updated: 2026-03-14T23:14:02.652954