SPL v2
SPL
SPL Set ID 737a502c-740b-4d00-806d-490346b621a2
Route
TOPICAL
Published
Effective Date 2023-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Wormwood Bassia Scoparia Fruit Origanum Dictamnus Flowering Top Smilax Glabra Whole Solidago Decurrens Fruiting Top Phellodendron Amurense Bark Euphorbia Fischeriana Root Gleditsia Sinensis Fruit Stemona Tuberosa Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-28
Description

Active ingredient: Clotrimazole 1%

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Uses:

  • Aids in Alleviating Symptoms.
  • Associated with Tinea Versicolor and Fungal infections, including Tinea Corporis, Tinea Cruris, Tinea Pedis, and Ringworm.
Dosage and Administration

Directions

  • 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 this product.
  • If the condition persists, consult a doctor.
Description

Active ingredient: Clotrimazole 1%

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

  • Irritation occurs.
  • There is no improvement within 4 weeks.
  • Discomfort persists.
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

Inactive Ingredients

  • Wormwood
  • Bassia
  • Origanum Dictamnus Flowering Top
  • Smilax Glabra Whole
  • Solidago Decurrens Fruiting Top
  • Phellodendron Amurense Bark
  • Euphorbia Fischeriana Root
  • Gleditsia Sinensis Fruit
  • Stemona Tuberosa Root
Section 53413-1

Questions?

[email protected]

Section 55105-1
  • Antifungal
Section 55106-9

Active ingredient:

  • Clotrimazole 1%
Package Label.principal Display Panel

Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Aids in Alleviating Symptoms.
  • Associated with Tinea Versicolor and Fungal infections, including Tinea Corporis, Tinea Cruris, Tinea Pedis, and Ringworm.
Dosage and Administration (34068-7)

Directions

  • 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 this product.
  • If the condition persists, consult a doctor.
Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • Irritation occurs.
  • There is no improvement within 4 weeks.
  • Discomfort persists.
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)

Inactive Ingredients

  • Wormwood
  • Bassia
  • Origanum Dictamnus Flowering Top
  • Smilax Glabra Whole
  • Solidago Decurrens Fruiting Top
  • Phellodendron Amurense Bark
  • Euphorbia Fischeriana Root
  • Gleditsia Sinensis Fruit
  • Stemona Tuberosa Root
Section 53413-1 (53413-1)

Questions?

[email protected]

Section 55105-1 (55105-1)
  • Antifungal
Section 55106-9 (55106-9)

Active ingredient:

  • Clotrimazole 1%
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:28.934518 · Updated: 2026-03-14T23:12:42.073607