SPL v3
SPL
SPL Set ID 0085f818-ae14-470a-a0ae-b91e224d1362
Route
TOPICAL
Published
Effective Date 2025-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Butylated Hydroxytoluene Alcohol Cetostearyl Alcohol Dimethyl Sulfoxide Edetate Disodium Ethylparaben Glycerin Mineral Oil Glyceryl Mono And Dipalmitostearate Petrolatum Glycereth-31 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-10 Until 2025-02-07

Description

Clotrimazole USP 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole USP 1%

Uses

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)

Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

20250207

Warnings
  • For external use only
  • Do not useon children under 2 years of age unless directed by a doctor. 
  • When using this product, avoid contact with eyes. 
  • Stop use and ask doctor if: irritation occurs, there is no improvement within 4 weeks (for athletes foot or ringworm) or within 2 weeks (for jock itch)
  • Keep this and all drugs out of reach of children. In case of a accidental ingestion, seek professional assistance or contact a Poison Control Center right away.
Directions

• Wash the affected area and dry thoroughly

• Apply a thin layer over affected area twice daily (morning and night), or as directed by a doctor.

• Supervise children in the use of this product.

• For athletes' foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.

• For athletes foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.

• If condition persists longer, consult a doctor.

• This product is not effective on the scalp or nails.

Active Ingredient

Clotrimazole USP 1%

Other Information

• Store at controlled room temperature 15 – 30 C (50 – 86F)

• Close cap tightly after use.

Inactive Ingredients

Alcohol, Butylated hydroxytoluene, Cetostearyl alcohol, Dimethyl sulfoxide, Edetate disodium, Ethylparaben, Glycerol, Mineral oil, Mono-and di-glycerides, Petrolatum, Polyoxyethylene lauryl ether, Purified water


Structured Label Content

Uses

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)

Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Purpose

Antifungal

20250207

Warnings
  • For external use only
  • Do not useon children under 2 years of age unless directed by a doctor. 
  • When using this product, avoid contact with eyes. 
  • Stop use and ask doctor if: irritation occurs, there is no improvement within 4 weeks (for athletes foot or ringworm) or within 2 weeks (for jock itch)
  • Keep this and all drugs out of reach of children. In case of a accidental ingestion, seek professional assistance or contact a Poison Control Center right away.
Directions

• Wash the affected area and dry thoroughly

• Apply a thin layer over affected area twice daily (morning and night), or as directed by a doctor.

• Supervise children in the use of this product.

• For athletes' foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.

• For athletes foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.

• If condition persists longer, consult a doctor.

• This product is not effective on the scalp or nails.

Active Ingredient

Clotrimazole USP 1%

Other Information (Other information)

• Store at controlled room temperature 15 – 30 C (50 – 86F)

• Close cap tightly after use.

Inactive Ingredients

Alcohol, Butylated hydroxytoluene, Cetostearyl alcohol, Dimethyl sulfoxide, Edetate disodium, Ethylparaben, Glycerol, Mineral oil, Mono-and di-glycerides, Petrolatum, Polyoxyethylene lauryl ether, Purified water


Advanced Ingredient Data


Raw Label Data

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