SPL v3
SPL
SPL Set ID 60cbd3aa-9ad7-24e4-e053-2a91aa0ab05f
Route
TOPICAL
Published
Effective Date 2017-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Propylene Glycol Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-07-05

Description

Clotrimazole 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole 1%

Uses

• cures most athlete’s foot infections and ringworm infections



• relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

For external use only

Flammable

Do not use near heat or ame, or while smoking. Cap tightly and store at room temperature away from heat.

Directions

• wash affected area and dry thoroughly



• apply one drop to the affected area twice daily (morning and night) or as directed by your doctor



• using a disposable cotton swab, spread a thin layer over the affected area



• discard cotton swab



• supervise children in the use of this product



• for athlete’s foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily



• for athlete’s foot and ringworm infections, use daily for 4 weeks



• this product is not effective on scalp or nails

Do Not Use

on children under 2 years of age unless directed by a doctor.







When using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Active Ingredient

Clotrimazole 1%

Other Information

Store at controlled room temperature.

Inactive Ingredients

Ethyl Alcohol (79%), Propylene Glycol

Principal Display Panel

Questions Or Suggestions?

1.855.763.8733 or visit us at www.thepodiatreecompany.com

Keep Out of Reach of Children.

In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Stop Use and Ask A Doctor Or Pharmacist If

• irritation occurs



• there is no improvement within 4 weeks


Structured Label Content

Uses

• cures most athlete’s foot infections and ringworm infections



• relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Purpose

Antifungal

Warnings

For external use only

Flammable

Do not use near heat or ame, or while smoking. Cap tightly and store at room temperature away from heat.

Directions

• wash affected area and dry thoroughly



• apply one drop to the affected area twice daily (morning and night) or as directed by your doctor



• using a disposable cotton swab, spread a thin layer over the affected area



• discard cotton swab



• supervise children in the use of this product



• for athlete’s foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily



• for athlete’s foot and ringworm infections, use daily for 4 weeks



• this product is not effective on scalp or nails

Do Not Use (Do not use)

on children under 2 years of age unless directed by a doctor.







When using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Active Ingredient

Clotrimazole 1%

Other Information

Store at controlled room temperature.

Inactive Ingredients

Ethyl Alcohol (79%), Propylene Glycol

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Questions Or Suggestions? (Questions or Suggestions?)

1.855.763.8733 or visit us at www.thepodiatreecompany.com

Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Stop Use and Ask A Doctor Or Pharmacist If (Stop use and ask a doctor or pharmacist if)

• irritation occurs



• there is no improvement within 4 weeks


Advanced Ingredient Data


Raw Label Data

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