ROYCEDERM SULFUR SOAP.- sulfur soap

RoyceDerm Sulfur Soap. by

Drug Labeling and Warnings

RoyceDerm Sulfur Soap. by is a Otc medication manufactured, distributed, or labeled by RoyceDerm LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sulfur 10.0%

PURPOSE

Acne Treatment

WHEN USING

For the treatment of acne.

DOSAGE & 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.

OTHER SAFETY INFORMATION

Store at room temperature and out of direct sunlight

QUESTIONS

Visit www.roycederm.com

WARNINGS

• 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.

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

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

INACTIVE INGREDIENT

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.

INDICATIONS & USAGE

Uses for the treatment of acne

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYCEDERM SULFUR SOAP. 
sulfur soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85424-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	23.2 g  in 232 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
STYPHNOLOBIUM JAPONICUM FLOWER BUD (UNII: DES4RX1Z3E)
ALOE (UNII: V5VD430YW9)
SORBITOL (UNII: 506T60A25R)
LAURIC ACID (UNII: 1160N9NU9U)
ELAEIS GUINEENSIS (PALM) OIL (UNII: 5QUO05548Z)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)
SALICYLIC ACID (UNII: O414PZ4LPZ)
COLEUS FORSKOHLII ROOT OIL (UNII: 5NXR7DJ9WO)
POTASSIUM COCOATE (UNII: F8U72V8ZXP)
LANOLIN (UNII: 7EV65EAW6H)
ASIAN GINSENG (UNII: CUQ3A77YXI)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85424-003-01	232 g in 1 CARTON; Type 0: Not a Combination Product	08/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	08/01/2025

Labeler - RoyceDerm LLC (130329531)