SODIUM SULFACETAMIDE, SULFUR- sodium sulfacetamide 10%, sulfur 5% liquid

SODIUM SULFACETAMIDE, SULFUR by

Drug Labeling and Warnings

SODIUM SULFACETAMIDE, SULFUR by is a Prescription medication manufactured, distributed, or labeled by Aspen Medical LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx Only

FOR EXTERNAL USE ONLY. NOT FOR INTRA VAGINAL OR OPHTHALMIC USE. (KEEP AWAY FROM EYES)

INACTIVE INGREDIENT

Aloe Vera Leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium Laureth Sulfate, Sodium Thiosulfate, Stearyl Alcohol, Triacetin, Xanthan Gum.

INDICATIONS & USAGE

Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea seborrheic dermatitis.

CAUTION

If redness or irritation occurs, discontinue use.

Call your doctor for medial advice about side effect.

DOSAGE & ADMINISTRATION

Wash affected areas once or twice daily, or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and leberally apply to areas to be cleansed, massage gently into skin for 10-20 seconds working into a full leather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing cleanser off sooner or using less often.

FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR OPTHALMIC USE. (KEEP AWAY FROM EYES).

KEEP OUT OF REACH OF CHILDREN

(Shake well before use)

STORAGE AND HANDLING

Store at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature. Protect from freezing.

In case of accidental ingestion contact a Poison Controll Center immediately. Keep container tightly closed.

You may report side effects by calling the FDA at 1-800-FDA-1088

DESCRIPTION

Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl)sulfonyl]-acetamide monosodium salt, monohydrate. The structural formula is:

CLINICAL PHARMACOLOGY

The most widely accepted mechanism of action of sulfonamides is the woods-fields theory which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (FABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological halflife has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown but it has been reported that it inhibits the growth of propionibacterium acnes andthe formation of free fatty acids.

CONTRAINDICATIONS

Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is not to be used by patients with kidney disease.

WARNINGS

Although it is rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.

GENERAL

If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.

INFORMATION FOR PATIENTS

Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

PREGNANCY
Category C

Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% & Sulfur 5% Cleanser. It is also not known whether Sodium Sulfacetamide 10% & Sulfur 5% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% & Sulfur 5% Cleanser should be given to a pregnant woman only if clearly needed.

PEDIATRIC USE

Safety and effectiveness in children under the age of 12 have not been established.

NURSING MOTHERS

It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 10% & Sulfur 5% Cleanser. However, small amounts of orally administered sulfonamides have milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is administered to a nursing woman.

ADVERSE REACTIONS

Although rare, sodium sulfacetamide may cause local irritation.

HOW SUPPLIED

Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is available in

6 oz (170 g) bottle NDC: 87026-202-06

12 oz (340 g) bottle NDC: 87026-202-12

SPL UNCLASSIFIED SECTION

This bottle is not filled to the top but does contain 6 oz of of product as identified on the front panel of the bottle.

SPL UNCLASSIFIED SECTION

USA Manufactured For:

Aspen Medical LLC

8 The Green Ste. B

Dover, DE 19901

Rev. 10/25

PRINCIPAL DISPLAY PANEL

Aspen Medical

NDC: 87026-202-06

Rx Only

Sodium

Sulfacetamide

& Sulfur

Sodium Sulfacetamide 10%

Sulfur 5%

10%/5%

Cleanser

For External Use only

NET WT. 6 OZ. (170 g)

INGREDIENTS AND APPEARANCE

SODIUM SULFACETAMIDE, SULFUR 
sodium sulfacetamide 10%, sulfur 5% liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 87026-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5)	SULFACETAMIDE SODIUM	100 mg  in 1 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SODIUM THIOSULFATE (UNII: HX1032V43M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TRIACETIN (UNII: XHX3C3X673)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
PEG-100 STEARATE (UNII: YD01N1999R)
CITRIC ACID (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87026-202-06	170 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2026
2	NDC: 87026-202-12	340 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2026

Labeler - Aspen Medical LLC (119562869)

Registrant - Aspen Medical LLC (119562869)