Roycederm Antifungal Soap

Roycederm Antifungal Soap
SPL v1
SPL
SPL Set ID 313162be-c33b-7790-e063-6394a90a3216
Route
TOPICAL
Published
Effective Date 2025-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Melaleuca Alternifolia (tea Tree) Leaf Oil Olea Europaea (olive) Fruit Oil Water Ceramide Np Sulfur Sorbitol Lauric Acid Elaeis Guineensis (palm) Oil Propylene Glycol Sodium Hydroxide Glycerin Sodium Dodecylbenzenesulfonate Sodium Myristate Sodium Glutamate Cocos Nucifera (coconut) Oil Stearic Acid Myristic Acid Hamamelis Virginiana (witch Hazel) Leaf Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-20

Description

Tolnaftate 1%


Medication Information

Warnings and Precautions

Forx external use only

Indications and Usage

Cures & prevents most athlete's foot(tinea pedis), jock itch(tinea cruris) & ringworm (tinea corporis).

Relieves itching, irritation, redness, scaling, and discomfort associated with these conditions.

Dosage and Administration

Wash the affected area thoroughly with water.

Lather the soap and apply it to the affected area.

Allow the lather to sit on the skin for 2-3 minutes before rinsing thoroughly.

For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.

Use 1-2 times daily for 4 weeks; if the condition persists longer, consult a doctor.

Supervise children in the use of this product.

Description

Tolnaftate 1%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

if condition worsens or does not improve after 4 weeks of regular use as directed.

Section 50567-7

avoid contact with the eyes. If contact occurs, rinse the eyes thoroughly with water.

Section 50570-1

on children under 2 years of age except under the advice and supervision of a doctor.

Section 51727-6

Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aqua (Water), Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate, Sulfur, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide NP.

Section 51945-4

Section 53413-1

Visit at www.roycederm.com

Section 55105-1

anti-fungal

Section 55106-9

Tolnaftate 1%

Section 60561-8

Store at room temperature.

Protect from freezing.


Structured Label Content

Indications and Usage (34067-9)

Cures & prevents most athlete's foot(tinea pedis), jock itch(tinea cruris) & ringworm (tinea corporis).

Relieves itching, irritation, redness, scaling, and discomfort associated with these conditions.

Dosage and Administration (34068-7)

Wash the affected area thoroughly with water.

Lather the soap and apply it to the affected area.

Allow the lather to sit on the skin for 2-3 minutes before rinsing thoroughly.

For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.

Use 1-2 times daily for 4 weeks; if the condition persists longer, consult a doctor.

Supervise children in the use of this product.

Warnings and Precautions (34071-1)

Forx external use only

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

if condition worsens or does not improve after 4 weeks of regular use as directed.

Section 50567-7 (50567-7)

avoid contact with the eyes. If contact occurs, rinse the eyes thoroughly with water.

Section 50570-1 (50570-1)

on children under 2 years of age except under the advice and supervision of a doctor.

Section 51727-6 (51727-6)

Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aqua (Water), Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate, Sulfur, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide NP.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Visit at www.roycederm.com

Section 55105-1 (55105-1)

anti-fungal

Section 55106-9 (55106-9)

Tolnaftate 1%

Section 60561-8 (60561-8)

Store at room temperature.

Protect from freezing.


Advanced Ingredient Data


Raw Label Data

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