Update-85398-002-01

Update-85398-002-01
SPL v2
SPL
SPL Set ID 32d71d7e-3c78-6b63-e063-6294a90adaed
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
Water Peppermint Oil Camphor (synthetic) Triethanolamine Glycerin Propylene Glycol Methylparaben Gentiana Lutea Root

Identifiers & Packaging

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

Clotrimazole 1%

Medication Information

Warnings and Precautions

For External Use Only

Indications and Usage

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

Dosage and Administration
  • Wash the affected area and dry thoroughly.
  • Apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor, supervise children in the use of the product.
  • If the condition persists longer, consult a doctor.
Description

Clotrimazole 1%

Section 44425-7

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

Section 50565-1

keep out of the reach of young children.

Section 50566-9

Stop Using and Ask a Physician if irritation occurs or there is no improvement within 4 weeks.

Section 50567-7

avoid contact with eyes, if contact occurs, rinse the eyes very thoroughly with water.

Section 50570-1

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

Section 51727-6

Purified Water, Camphor, Gentiana Lutea Root, Propylene Glycol, Glycerin, Methylparaben, Triethanolamine, Peppermint Oil

Section 51945-4

Section 53413-1

[email protected]

Section 55105-1

Antifungal

Section 55106-9

Clotrimazole 1%

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)
  • Wash the affected area and dry thoroughly.
  • Apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor, supervise children in the use of the product.
  • If the condition persists longer, consult a doctor.
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 the reach of young children.

Section 50566-9 (50566-9)

Stop Using and Ask a Physician if irritation occurs or there is no improvement within 4 weeks.

Section 50567-7 (50567-7)

avoid contact with eyes, if contact occurs, rinse the eyes very thoroughly with water.

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Purified Water, Camphor, Gentiana Lutea Root, Propylene Glycol, Glycerin, Methylparaben, Triethanolamine, Peppermint Oil

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

[email protected]

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: 2026-02-15T12:06:06.522392 · Updated: 2026-03-14T23:14:01.507604