SODIUM SULFACETAMIDE 9.8 % AND SULFUR 4.8 % CLEANSER- sodium sulfacetamide and sulfur lotion

Sodium Sulfacetamide 9.8 % and Sulfur 4.8 % Cleanser by

Drug Labeling and Warnings

Sodium Sulfacetamide 9.8 % and Sulfur 4.8 % Cleanser by is a Prescription medication manufactured, distributed, or labeled by SOHM, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

For Topical use only

Not for Ophthalmic use

Rx Only

DESCRIPTION:

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

Each gram of Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser contains 98 mg of Sodium Sulfacetamide and 48 mg of sulfur in a formulation containing: Aloe Vera Leaf, Butylated Hydroxytoluene, Camellia Oleifera Leaf, Cetyl Alcohol, Disodium Oleamido Monoethanolamine Sulfosuc­cinate, Edetate Disodium, Glycerin, Glyceryl Monostearate, Magnesium Aluminum Silicate, Methylparaben, Peg-100 Stearate, Propylparaben, Sodium Cocoyl lsethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol, Water, Xanthan Gum.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY:

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

INDICATIONS & USAGE

INDICATIONS: Sulfacetamide Sodium and Sulfur Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS

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

WARNINGS

WARNINGS:

Although rare, sensitivity to Sulfacetaminde Sodium 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.

SPL UNCLASSIFIED SECTION

FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.

PRECAUTIONS:

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 Sulfacetamide Sodium 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 and 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 Sulfacetamide Sodium and Sulfur lotion. It is also not known whether Sulfacetamide Sodium and Sulfur cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide Sodium and Sulfur cleanser should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS

Nursing Mothers - It is not known whether sulfacetamide sodium is excreted in the human milk following topical use of Sulfacetamide Sodium and Sulfur lotion. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sulfacetamide Sodium and Sulfur cleanser is administered to a nursing woman.

PEDIATRIC USE

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

ADVERSE REACTIONS

ADVERSE REACTIONS: Although rare, Sulfacetamide Sodium may cause local irritation.

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION: Use once daily or as directed by your physician. Wet skin. Apply in a film to entire face, avoiding contact with eyes or mucous membranes. Wait 10 minutes or until dry. Rinse thoroughly with water and pat dry.

HOW SUPPLIED

HOW SUPPLIED:

Sulfacetamide Sodium 9.8% and Sulfur 4.8% cleanser is supplied in
10 oz (285 g) bottle NDC #50405-852-01

Store at 20°-25°C (68°-77°F), excursions permitted between 15°-30°C (59°-86°F). Brief exposure to temperatures up to 40° (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C(77°F); however such exposure should be minimized. Protect from freezing.

Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

SPL UNCLASSIFIED SECTION

Rx Only

Manufactured for: SOHM, Inc. 2501 Commercial St., San Diego, CA 92113 USA

For any product questions or concerns please call: 800-284-1524
Rev. 04-2023

PRINCIPAL DISPLAY PANEL - 285 g Bottle Label

NDC: 50405-852-01

Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser

Rx Only

10 oz (285 g)

INGREDIENTS AND APPEARANCE

SODIUM SULFACETAMIDE 9.8 % AND SULFUR 4.8 % CLEANSER 
sodium sulfacetamide and sulfur lotion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 50405-852
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5)	SULFACETAMIDE SODIUM	98 mg  in 1 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	48 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
CETYL ALCOHOL (UNII: 936JST6JCN)
DISODIUM OLEAMIDO MEA-SULFOSUCCINATE (UNII: 5M1101WGSY)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
SODIUM THIOSULFATE (UNII: HX1032V43M)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50405-852-01	285 g in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/03/2023

Labeler - SOHM, Inc (009303848)

Registrant - SOHM, Inc (009303848)