Quality Choice Clotrimazole Cream Usp, 1%

Quality Choice Clotrimazole Cream Usp, 1%
SPL v3
SPL
SPL Set ID acc2baee-5762-3239-e053-2995a90ac48c
Route
TOPICAL
Published
Effective Date 2019-09-23
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 FINAL Active Since 2020-08-13

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 right away.

Warnings

For External Use Only

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

● When using this product avoid contact with eyes.

Packaging

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.

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, Glyceryl Stearate SE, Laureth-23, Light Mineral Oil, Petrolatum, Stearyl Alcohol, Water

Questions Or Comments?

DISTRIBUTED BY: CDMA Inc.

43157 W 9 Mile Rd.

Novi, MI. 48375

This product is not manufactured or distributed by Bayer Consumer Care, Inc. owner of the registered trademark Lotrimin® AF

Product of PRC

Stop Use and Ask A Doctor If:
  • irritation occurs
  • there is no improvement within 4 weeks (for Athlete's foot or ringwork) or within 2 weeks (for jock itch).

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 right away.

Purpose

Antifungal Cream

Warnings

For External Use Only

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

● When using this product avoid contact with eyes.

Packaging

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.

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, Glyceryl Stearate SE, Laureth-23, Light Mineral Oil, Petrolatum, Stearyl Alcohol, Water

Questions Or Comments? (Questions or Comments?)

DISTRIBUTED BY: CDMA Inc.

43157 W 9 Mile Rd.

Novi, MI. 48375

This product is not manufactured or distributed by Bayer Consumer Care, Inc. owner of the registered trademark Lotrimin® AF

Product of PRC

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 ringwork) or within 2 weeks (for jock itch).

Advanced Ingredient Data


Raw Label Data

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