Quality Choice Clotrimazole Cream Usp, 1%

Quality Choice Clotrimazole Cream Usp, 1%
SPL v1
SPL
SPL Set ID 24ff5ad7-2ff9-b254-e063-6394a90a27a7
Route
TOPICAL
Published
Effective Date 2024-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-13

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

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, Glycerol, Alcohol, Butylated hydroxytoluene, Cetostearyl alcohol, Edetate disodium, Mineral oil, mono and di glycerides, petrolatum, Polyoxyethylene lauryl ether, purified water.

Questions Or Comments?

DISTRIBUTED BY: CDMA Inc.

Novi, MI. 48375

www.qualitychoice.com

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

Stop Use and Ask A Doctor If:

On children under 2 years of age unless directed by doctor.


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)

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, Glycerol, Alcohol, Butylated hydroxytoluene, Cetostearyl alcohol, Edetate disodium, Mineral oil, mono and di glycerides, petrolatum, Polyoxyethylene lauryl ether, purified water.

Questions Or Comments? (Questions or Comments?)

DISTRIBUTED BY: CDMA Inc.

Novi, MI. 48375

www.qualitychoice.com

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

Stop Use and Ask A Doctor If: (Stop Use and ask a Doctor if:)

On children under 2 years of age unless directed by doctor.


Advanced Ingredient Data


Raw Label Data

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