Clotrimazole Cream 1% - Antifungal Cream

Clotrimazole Cream 1% - Antifungal Cream
SPL v4
SPL
SPL Set ID a3424c66-68ee-0631-e053-2995a90a3e7a
Route
TOPICAL
Published
Effective Date 2020-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Mineral Oil Propylparaben Water Ceteth-20 Cetostearyl Alcohol Petrolatum Propylene Glycol Methylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-04-14

Description

Clotrimazole 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole 1%

Usage
  • For External treatment of most athlete's foot (tinea pedis), jock ithc (tinea crusis), ringworm (tinea corporis).
  • Relieves itching, cracking scaling irritation and chafing associated with these conditions.
Section 50565-1

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

Warnings

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

For external use only.

Avoid contact with eyes.

If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch), discontinue use and consult a doctor.

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.

Directions
  • Clean the affected area and dry thoroughly. Apply a layer of cream over the affected area twice daily morning and night or as directed by doctor.
  • Supervise children in the use of this product.
  • For athlete's foot pay special attention to the spaces between 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 condition persist longer consult a doctor.
  • This product is not effective on scalp or nails.
Active Ingredient

Clotrimazole 1%

Other Information
  • Store between 20ºC and 25ºC (68ºF and 77ºF)

Questions or comments?

Call 1-866-747-7365

Inactive Ingredients

Cetomacragol 1000, Cetostearyl alcohol, Liquid paraffin, Methyl Paraben, Propyl paraben, Propylene glycol, Purified water, White soft paraffin.

Package Display Panel

Questions or comments?

Call 1-866-747-7365

Manufactured for : SOLA Pharmaceuticals



Baton Rouge, LA 70810



Store in a dry, cool place



For Comments or Questions, call 866-747-7365

Clotrimazole 1% Cream



NDC 70512-100-30



Qty: 28.4g

NDC 70512-100-15

QTY 14.2


Structured Label Content

Usage
  • For External treatment of most athlete's foot (tinea pedis), jock ithc (tinea crusis), ringworm (tinea corporis).
  • Relieves itching, cracking scaling irritation and chafing associated with these conditions.
Section 50565-1 (50565-1)

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

Purpose

Antifungal

Warnings

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

For external use only.

Avoid contact with eyes.

If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch), discontinue use and consult a doctor.

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.

Directions
  • Clean the affected area and dry thoroughly. Apply a layer of cream over the affected area twice daily morning and night or as directed by doctor.
  • Supervise children in the use of this product.
  • For athlete's foot pay special attention to the spaces between 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 condition persist longer consult a doctor.
  • This product is not effective on scalp or nails.
Active Ingredient

Clotrimazole 1%

Other Information
  • Store between 20ºC and 25ºC (68ºF and 77ºF)

Questions or comments?

Call 1-866-747-7365

Inactive Ingredients

Cetomacragol 1000, Cetostearyl alcohol, Liquid paraffin, Methyl Paraben, Propyl paraben, Propylene glycol, Purified water, White soft paraffin.

Package Display Panel

Questions or comments?

Call 1-866-747-7365

Manufactured for : SOLA Pharmaceuticals



Baton Rouge, LA 70810



Store in a dry, cool place



For Comments or Questions, call 866-747-7365

Clotrimazole 1% Cream



NDC 70512-100-30



Qty: 28.4g

NDC 70512-100-15

QTY 14.2


Advanced Ingredient Data


Raw Label Data

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