Clotrimazole Cream Usp, 1%

Clotrimazole Cream Usp, 1%
SPL v5
SPL
SPL Set ID 915759af-0d7b-6a87-e053-2a95a90acbd6
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 DRUG Active Since 2019-08-30

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, burning, cracking, scaling and discomfort which can accompany these conditions.

Section 50565-1

Keep this and all drugs out of the reach of children. If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Warnings

Do not use on children under 2 years of age except under the advice of a doctor.

● For external use only

● 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 20°-25°C (68°- 77°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?

Call 1-888-296-9067 Mon-Fri 9AM - 5PM

DISTRIBUTED BY: MIDWOOD BRANDS, LLC.

500 Volvo Parkway, Chesapeake, VA. 23320

NOT SATISFIED?

Return Package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

This product is not manufactured or distributed by Bayer, owner of the registered trademark Lotrimin®

If Pregnant Or Breastfeeding

If Pregnant or breastfeeding, ask a health professional before use.

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, burning, cracking, scaling and discomfort which can accompany these conditions.

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children. If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Purpose

Antifungal Cream

Warnings

Do not use on children under 2 years of age except under the advice of a doctor.

● For external use only

● 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 20°-25°C (68°- 77°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?)

Call 1-888-296-9067 Mon-Fri 9AM - 5PM

DISTRIBUTED BY: MIDWOOD BRANDS, LLC.

500 Volvo Parkway, Chesapeake, VA. 23320

NOT SATISFIED?

Return Package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

This product is not manufactured or distributed by Bayer, owner of the registered trademark Lotrimin®

If Pregnant Or Breastfeeding (If Pregnant or breastfeeding)

If Pregnant or breastfeeding, ask a health professional before use.

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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