clotrimazole cream usp, 1%

clotrimazole cream usp, 1%
SPL v5
SPL
SPL Set ID a1365bc7-b376-adca-e053-2a95a90acf19
Route
topical
Published
Effective Date 2024-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
clotrimazole (1 g)
Inactive Ingredients
dimethyl sulfoxide ethylparaben glycerin glyceryl stearate se laureth-23 light mineral oil petrolatum stearyl alcohol water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2020-03-19

Purpose

Antifungal Cream

Description

Clotrimazole USP 1% w/w


Medication Information

Warnings

For external use only

● Do not use on children under 2 years of age unless directed by a doctor.

● Avoid contact with eyes.

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.

Purpose

Antifungal Cream

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.

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

Dimethyl Sulfoxide, Ethylparaben, Glycerin, Glyceryl Stearate SE, Laureth-23, Light Mineral Oil, Petrolatum, Stearyl Alcohol, Water

Description

Clotrimazole USP 1% w/w

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

Questions

Keep carton for complete Drug Facts

Call 1-800-645-2158

Distributed by:

RUGBY® LABORATORIES

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Made in China

Package Label

Active Ingredient

Clotrimazole USP 1% w/w

Packaging and Label

Stop Use and Ask A Doctor If
  • Irritation occurs
  • There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).

Structured Label Content

Warnings

For external use only

● Do not use on children under 2 years of age unless directed by a doctor.

● Avoid contact with eyes.

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.

Purpose

Antifungal Cream

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.

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

Dimethyl Sulfoxide, Ethylparaben, Glycerin, Glyceryl Stearate SE, Laureth-23, Light Mineral Oil, Petrolatum, Stearyl Alcohol, Water

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)

Questions

Keep carton for complete Drug Facts

Call 1-800-645-2158

Distributed by:

RUGBY® LABORATORIES

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Made in China

Package Label

Active Ingredient (Active ingredient)

Clotrimazole USP 1% w/w

Packaging and Label

Stop Use and Ask A Doctor If (Stop Use and ask a doctor if)
  • Irritation occurs
  • There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).

Advanced Ingredient Data


Raw Label Data

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