Initial Drug Listing - Roycederm Sulfur Soap Bar

Initial Drug Listing - Roycederm Sulfur Soap Bar
SPL v1
SPL
SPL Set ID 3a323a77-eff4-973f-e063-6394a90a02a0
Route
TOPICAL
Published
Effective Date 2025-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (23.2 g)
Inactive Ingredients
Water Olea Europaea (olive) Fruit Oil Styphnolobium Japonicum Flower Bud Aloe Sorbitol Lauric Acid Elaeis Guineensis (palm) Oil Cocos Nucifera (coconut) Oil Stearic Acid Glycerin Salicylic Acid Coleus Forskohlii Root Oil Potassium Cocoate Lanolin Asian Ginseng Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

Sulfur 10.0%


Medication Information

Warnings and Precautions
  • For external use only.
  • Apply solely to acne-affected areas.Use caution when combining with other topical acne medications to prevent skin
  • irritation and dryness.
  • Avoid use on broken or large skin areas.
  • Discontinue use and consult a doctor ifexcessive skin irritation occurs.
  • When using this product avoid contact with eyes. lf contact occurs, rinse the eyes thoroughly with water.
Indications and Usage

Uses for the treatment of acne

Dosage and Administration

Create a rich lather with the mesh bag, gently apply to affected areas, leaving it on the skin for 3 to 5 minutes. Rinse thoroughly with waterand pat dry with a clean towel. Incorporate into your routine 1 to 3 times a day, or as directed by a doctor, for optimal results.

Description

Sulfur 10.0%

Section 50565-1

lf swallowed, get medical help or contact a Poison Control center(1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if condition worsens or does not improve after regula ruse as directed.

Section 50567-7

For the treatment of acne.

Section 51727-6

Water, Olea Europaea Fruit Oil, 0,25% Salicylic Acid, Lauric Acid, Stearic Acid,Sorbitol,Glycerin, Cocos Nucifera Oil, Elaeis Guineensis Oil, Botanical Acaricide.Potassium Cocoate, Lanolin, Sophor ajaponica Extract, Aloe Extract, Sulfur Spring Extract, Ginseng, Coleus Forskohlii Root Oil, Tea Tree Essential Oil.

Section 51945-4

Section 53413-1

Visit www.roycederm.com

Section 55105-1

Acne Treatment

Section 55106-9

Sulfur 10.0%

Section 60561-8

Store at room temperature and out of direct sunlight


Structured Label Content

Indications and Usage (34067-9)

Uses for the treatment of acne

Dosage and Administration (34068-7)

Create a rich lather with the mesh bag, gently apply to affected areas, leaving it on the skin for 3 to 5 minutes. Rinse thoroughly with waterand pat dry with a clean towel. Incorporate into your routine 1 to 3 times a day, or as directed by a doctor, for optimal results.

Warnings and Precautions (34071-1)
  • For external use only.
  • Apply solely to acne-affected areas.Use caution when combining with other topical acne medications to prevent skin
  • irritation and dryness.
  • Avoid use on broken or large skin areas.
  • Discontinue use and consult a doctor ifexcessive skin irritation occurs.
  • When using this product avoid contact with eyes. lf contact occurs, rinse the eyes thoroughly with water.
Section 50565-1 (50565-1)

lf swallowed, get medical help or contact a Poison Control center(1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens or does not improve after regula ruse as directed.

Section 50567-7 (50567-7)

For the treatment of acne.

Section 51727-6 (51727-6)

Water, Olea Europaea Fruit Oil, 0,25% Salicylic Acid, Lauric Acid, Stearic Acid,Sorbitol,Glycerin, Cocos Nucifera Oil, Elaeis Guineensis Oil, Botanical Acaricide.Potassium Cocoate, Lanolin, Sophor ajaponica Extract, Aloe Extract, Sulfur Spring Extract, Ginseng, Coleus Forskohlii Root Oil, Tea Tree Essential Oil.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Visit www.roycederm.com

Section 55105-1 (55105-1)

Acne Treatment

Section 55106-9 (55106-9)

Sulfur 10.0%

Section 60561-8 (60561-8)

Store at room temperature and out of direct sunlight


Advanced Ingredient Data


Raw Label Data

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