Clotrimazole Cream Usp, 1%

Clotrimazole Cream Usp, 1%
SPL v1
SPL
SPL Set ID 0052992a-819c-4c55-bd88-201a09a3573a
Route
TOPICAL
Published
Effective Date 2025-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Mineral Oil Dimethyl Sulfoxide Ethylparaben Glycerin Laureth-23 Petrolatum Water Edetate Disodium Glyceryl Mono- And Dipalmitostearate Butylated Hydroxytoluene Alcohol Cetostearyl Alcohol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-21

Description

Clotrimazole USP 1% w/w

Purpose

Antifungal Cream


Medication Information

Purpose

Antifungal Cream

Description

Clotrimazole USP 1% w/w

Uses

Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Section 50565-1

Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Section 51945-4
Warnings

For External use only.

Directions
  • Wash the affected area and dry thoroughly.

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

● Supervise children in the use of this product.

● For athlete’s 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 athlete’s foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.

● If conditions persists longer, consult a doctor.

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

Do Not Use

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

Questions?

Adverse drug event call 1-888-296-9067



Dist. By Trifecta Pharmaceuticals USA®



101 NE Third Avenue, Suite 1500



Ft. Lauderdale, FL 33301, USA

Relabeled By: Preferred Pharmaceuticals Inc.

NDC 68788-8330-2

Active Ingredient

Clotrimazole USP 1% w/w

Other Information
  • store at controlled room temperature 15°-30°C (59°- 86°F)
  • Close cap tightly after use.
Inactive Ingredients

Dimethyl Sulfoxide, Ethylparaben, Glycerin, Laureth-23, Mineral Oil, Petrolatum, Water, alcohol, Glyceryl mono and dipalmitostearate, Cetostearyl alcohol, edetate disodium, Butylated Hydroxytoluene.

When Using This Product

When using this product avoid contact with eyes

Stop Use and Ask Doctor If
  • irritaion occurs
  • There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).
Keep This and All Drugs Out of the Reach of Children

In case of accidental ingestion, seek professional assistance or contact Poison Control Centre right away.


Structured Label Content

Uses

Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Section 51945-4 (51945-4)
Purpose

Antifungal Cream

Warnings

For External use only.

Directions
  • Wash the affected area and dry thoroughly.

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

● Supervise children in the use of this product.

● For athlete’s 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 athlete’s foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.

● If conditions persists longer, consult a doctor.

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

Do Not Use

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

Questions?

Adverse drug event call 1-888-296-9067



Dist. By Trifecta Pharmaceuticals USA®



101 NE Third Avenue, Suite 1500



Ft. Lauderdale, FL 33301, USA

Relabeled By: Preferred Pharmaceuticals Inc.

NDC 68788-8330-2

Active Ingredient (Active ingredient)

Clotrimazole USP 1% w/w

Other Information
  • store at controlled room temperature 15°-30°C (59°- 86°F)
  • Close cap tightly after use.
Inactive Ingredients

Dimethyl Sulfoxide, Ethylparaben, Glycerin, Laureth-23, Mineral Oil, Petrolatum, Water, alcohol, Glyceryl mono and dipalmitostearate, Cetostearyl alcohol, edetate disodium, Butylated Hydroxytoluene.

When Using This Product (When using this product)

When using this product avoid contact with eyes

Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • irritaion occurs
  • There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).
Keep This and All Drugs Out of the Reach of Children (Keep this and all drugs out of the reach of children)

In case of accidental ingestion, seek professional assistance or contact Poison Control Centre right away.


Advanced Ingredient Data


Raw Label Data

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