SPL v2
SPL
SPL Set ID 2ba7a7a0-8a04-2353-e063-6294a90a93b8
Route
TOPICAL
Published
Effective Date 2022-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Urea (15 g)
Inactive Ingredients
Propylparaben Petrolatum Calcium Disodium Edta Water Glycerin Paraffinum Liquidum Cetearyl Alcohol Steareth-21 Steareth-2 Phenoxyethanol Dimethicone Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%)

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-10-01

Description

Clotrimazole----1%----Antifungal


Medication Information

Description

Clotrimazole----1%----Antifungal

Uses

Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves itching, cracking, scaling, burning, irritation and discomforts which accompany these conditions.

Lable

Warning

For external use only.

Directions

*Wash affected area and dry thoroughly

* Apply twice daily (morning and night) over the affected area , or as directed by a physician.

* Use daily for 4 weeks, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.

* Supervise children in the use of this product.

* This product is not proven to be effective on scalp or nails.

* Wash hands after each use.

Ask A Doctor If

use on children less than 2 years of age unless directed by a doctor

Other Information

Store at room temperature.

Active Ingredients

Clotrimazole----1%----Antifungal

Inactive Ingredients

Purify water, dictamnus dasycarpus root, cnidium monnieri fruit, menthol, magnolia sieboldii root, stellera chamaejasme whole, sophora flavescens root, bassia scoparia fruit.

Dosage & Administration

Apply as needed

When Using This Product

Do not get into eyes.

Stop Use and Ask A Doctor If

Irritation occurs or there is no improvement of athlete's foot or ringworm within 4 weeks or jock intch with 2 weeks.

Keep Out of Reach of Children.

if swallowed, call poison control or seek medical help.


Structured Label Content

Uses (USES)

Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves itching, cracking, scaling, burning, irritation and discomforts which accompany these conditions.

Lable

Warning

For external use only.

Directions

*Wash affected area and dry thoroughly

* Apply twice daily (morning and night) over the affected area , or as directed by a physician.

* Use daily for 4 weeks, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.

* Supervise children in the use of this product.

* This product is not proven to be effective on scalp or nails.

* Wash hands after each use.

Ask A Doctor If (Ask a doctor if)

use on children less than 2 years of age unless directed by a doctor

Other Information (Other information)

Store at room temperature.

Active Ingredients (Active ingredients)

Clotrimazole----1%----Antifungal

Inactive Ingredients (Inactive ingredients)

Purify water, dictamnus dasycarpus root, cnidium monnieri fruit, menthol, magnolia sieboldii root, stellera chamaejasme whole, sophora flavescens root, bassia scoparia fruit.

Dosage & Administration (Dosage & administration)

Apply as needed

When Using This Product (When using this product)

Do not get into eyes.

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

Irritation occurs or there is no improvement of athlete's foot or ringworm within 4 weeks or jock intch with 2 weeks.

Keep Out of Reach of Children. (Keep out of reach of children.)

if swallowed, call poison control or seek medical help.


Advanced Ingredient Data


Raw Label Data

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