SPL v2
SPL
SPL Set ID 3ca20a09-0a55-6f38-e063-6294a90a44be
Route
TOPICAL
Published
Effective Date 2025-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ketoconazole (1 g)
Inactive Ingredients
Elaeis Guineensis (palm) Oil Water Calendula Officinalis Whole Hydrogenated Jojoba Oil Propolis Wax Glycerin Beeswax Sucrose Myristic Acid Sodium Stearate Sodium Dodecylbenzenesulfonate Lauric Acid

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-02-01
Description

Ketoconazole 1%---------- Anti-fungal

Dosage and Administration

First, wet your skin. Then lather the soap in your hands, and apply the lather to your face or body in a circular motion. Leave on skin for two minutes, then rinse completely and pat dry gently.

Medication Information

Indications and Usage

First, wet your skin. Then lather the soap in your hands, and apply the lather to your face or body in a circular motion. Leave on skin fortwo minutes, then rinse completely and pat dry gently.

Dosage and Administration



First, wet your skin. Then lather the soap in

your hands, and apply the lather to your face

or body in a circular motion. Leave on skin for

two minutes, then rinse completely and pat dry

gently.

Description

Ketoconazole 1%---------- Anti-fungal

Uses

Relieves itching, irritation, dryness, redness and discomfort associated with skin issues in the private parts, buttocks, and groin area.

Lable

Stop Use



Stop use and ask a doctor if rash or irritation appears or if any

adverse reactions occur

Warnings



For external use only

Ask A Doctor



Stop use and ask

a doctor if rash or irritation appears or if any

adverse reactions occur

Other Information



Store at room temperature.

Active Ingredients

Ketoconazole 1%---------- Anti-fungal

Inactive Ingredients

Water, Beeswax, Calendula officinalisextract, Elaeis guineensis (palm) oiGlycerin, Hydrogenated jojoba oil,Lauric acid, Myristic acid, Propyleneglycol, Sodium dodecyl sulfate,Sodium stearate, Sorbitol, Sucrose.

When Using This Product



avoid contact with the eyes

Keep Out of Reach of Children

If swallowed, call a poison control center or seek medical attention immediately.

Structured Label Content

Uses

Relieves itching, irritation, dryness, redness and discomfort associated with skin issues in the private parts, buttocks, and groin area.

Lable

Indications and Usage (34067-9)

First, wet your skin. Then lather the soap in your hands, and apply the lather to your face or body in a circular motion. Leave on skin fortwo minutes, then rinse completely and pat dry gently.

Stop Use (Stop use)



Stop use and ask a doctor if rash or irritation appears or if any

adverse reactions occur

Warnings



For external use only

Ask A Doctor (Ask a doctor)



Stop use and ask

a doctor if rash or irritation appears or if any

adverse reactions occur

Other Information (Other information)



Store at room temperature.

Active Ingredients (Active ingredients)

Ketoconazole 1%---------- Anti-fungal

Inactive Ingredients

Water, Beeswax, Calendula officinalisextract, Elaeis guineensis (palm) oiGlycerin, Hydrogenated jojoba oil,Lauric acid, Myristic acid, Propyleneglycol, Sodium dodecyl sulfate,Sodium stearate, Sorbitol, Sucrose.

When Using This Product (When using this product)



avoid contact with the eyes

Dosage and Administration (Dosage and administration)



First, wet your skin. Then lather the soap in

your hands, and apply the lather to your face

or body in a circular motion. Leave on skin for

two minutes, then rinse completely and pat dry

gently.

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

If swallowed, call a poison control center or seek medical attention immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:47.971381 · Updated: 2026-03-14T23:13:40.815212