Initial Drug Listing - Roycederm Anti-fungal Relief Cream

Initial Drug Listing - Roycederm Anti-fungal Relief Cream
SPL v1
SPL
SPL Set ID 47ec6277-e40f-af82-e063-6294a90ac8c1
Route
TRANSDERMAL
Published
Effective Date 2026-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Artemisia Afra Top (3 g) Salicylic Acid (2 g)
Inactive Ingredients
Bassia Scoparia Pollen Dictamnus Dasycarpus Root Smilax Glabra Whole Sophora Flavescens Root Cnidium Monnieri Fruit Water Borneol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-23
Description

Artemisia extract 3% Salicylic acid 2%

Medication Information

Warnings and Precautions

FOR EXTERNAL USE ONLY

Indications and Usage
  • Apply a small amount to the problem areas with circular motions for 3 minutes till the skin absorbs the cream.
  • Apply it 2-3 times a day for the best result.
  • Continue to use for 3-5 days after symptoms resolve to prevent a recurrence
  • Do not use it on pregnant women & children under 12 years of age unless directed by a doctor.
Dosage and Administration

Relieves and helps prevent recurrence of fungal infections:itching, flaking, scaling, redness,and irritation.

Description

Artemisia extract 3% Salicylic acid 2%

Section 50565-1

If swalloWed,get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

condition worsens or does not improve after regular use as directed.

Section 50567-7

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

Section 50569-3

if you are allergic to ingredients in this product.

Section 51727-6

Water, Borneol, Sophora Flavescens Root, Cnidium Monnieri Fruit, Kochia Scoparia Pollen, Dictamnus Dasycarpus Root, Smilax Glabra Whole.

Section 51945-4

Section 53413-1

Visit www.roycederm.com

Section 55105-1

Anti-fungal

Section 55106-9

Artemisia extract 3%

Salicylic acid 2%

Section 60561-8

Store at room temperature and out of direct sunlight

Structured Label Content

Indications and Usage (34067-9)
  • Apply a small amount to the problem areas with circular motions for 3 minutes till the skin absorbs the cream.
  • Apply it 2-3 times a day for the best result.
  • Continue to use for 3-5 days after symptoms resolve to prevent a recurrence
  • Do not use it on pregnant women & children under 12 years of age unless directed by a doctor.
Dosage and Administration (34068-7)

Relieves and helps prevent recurrence of fungal infections:itching, flaking, scaling, redness,and irritation.

Warnings and Precautions (34071-1)

FOR EXTERNAL USE ONLY

Section 50565-1 (50565-1)

If swalloWed,get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

condition worsens or does not improve after regular use as directed.

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

if you are allergic to ingredients in this product.

Section 51727-6 (51727-6)

Water, Borneol, Sophora Flavescens Root, Cnidium Monnieri Fruit, Kochia Scoparia Pollen, Dictamnus Dasycarpus Root, Smilax Glabra Whole.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Visit www.roycederm.com

Section 55105-1 (55105-1)

Anti-fungal

Section 55106-9 (55106-9)

Artemisia extract 3%

Salicylic acid 2%

Section 60561-8 (60561-8)

Store at room temperature and out of direct sunlight

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:19.443681 · Updated: 2026-03-14T23:12:31.383435