Sodium Sulfacetamide 10 Sulfur 2 Cream

SODIUM SULFACETAMIDE 10 SULFUR 2 CREAM- sulfacetamide sodium and sulfur cream
Acella Pharmaceuticals, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Rx Only

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:

Chemical Structure
(click image for full-size original)

Each gram of Sodium Sulfacetamide 10% Sulfur 2% Cream contains 100 mg of Sodium Sulfacetamide and 20 mg of Sulfur in a base containing BHT, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol,Disodium EDTA, Ethylhexyl Palmitate, Ethylparaben, Fragrance, Glyceryl Monostearate SE, Methylparaben, Phenoxyethanol, Propylene Glycol, Propylparaben, Purified Water, Sodium Thiosulfate and Xanthan Gum.

CLINICAL PHARMACOLOGY:

Sodium Sulfacetamide exhibits antibacterial activity. It is believed to block bacterial growth by acting as a competitive antagonist of para-aminobenzoic acid (PABA). While absorption through intact skin has not been determined for sodium sulfacetamide, it is estimated that 1% of topically applied sulfur is absorbed. Although the exact mode of the keralytic activity of sulfur is unknown, it is reported to result from the interaction of sulfur with the cysteine content of keratinocytes. In combination with sulfacetamide, sulfur has been reported to inhibit P. acnes , thereby reducing the associated inflammation.

INDICATIONS:

Sodium Sulfacetamide 10% Sulfur 2% Cream is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS:

Sodium Sulfacetamide 10% Sulfur 2% Cream is contraindicated foruse by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% Sulfur 2% Cream is not to be used by patients with kidney disease.

WARNINGS:

Although rare, sensitivity to sodium sulfacetaminde 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.

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 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 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 Sodium Sulfacetamide 10% Sulfur 2% Cream. It is not known whether Sodium Sulfacetamide 10% Sulfur 2% Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% Sulfur 2% Cream should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS: It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 10% Sulfur 2% Cream. 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 Sodium Sulfacetamide 10% Sulfur 2% Cream is administered to a nursing woman.

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

ADVERSE REACTIONS:

Although rare, sodium sulfacetamide may cause local irritation.

DOSAGE AND ADMINISTRATION:

Cleanse skin thoroughly before application. Apply a thin layer to affected areas 1-3 times daily or as directed by a physician. To minimize potential dryness, start with one application daily, then gradually increase to 2-3 times daily as needed or as directed by a physician.

HOW SUPPLIED:

Sodium Sulfacetamide 10% Sulfur 2% Cream is available in 2 oz (57 g) tubes, NDC 42192-150-02.

Store at 20° — 25°C (68° — 77°F); excursions permitted to 15° — 30°C (59° — 86°F) [see USP Controlled Room Temperature]

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. NOTE: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.

MANUFACTURED FOR: Acella Pharmaceuticals, LLC
Alpharetta, GA 30022 • 1-800-541-4802

Rev. 0514

PRINCIPAL DISPLAY PANEL — 57 g Tube Label

NDC 42192-150-02

Rx Only

Sulfacetamide Sodium 10% Sulfur 2% Cream

Net wt. 2 oz (57 g)

Acella
PHARMACEUTICALS, LLC

PRINCIPAL DISPLAY PANEL -- 170.3 g Bottle Label
(click image for full-size original)
SODIUM SULFACETAMIDE 10 SULFUR 2 CREAM
sulfacetamide sodium and sulfur cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42192-150
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg in 1 g
SULFUR (SULFUR) SULFUR 20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
POLYOXYL 20 CETOSTEARYL ETHER
CETOSTEARYL ALCOHOL
CETYL ALCOHOL
EDETATE DISODIUM
ETHYLHEXYL PALMITATE
ETHYLPARABEN
GLYCERYL MONOSTEARATE
METHYLPARABEN
PHENOXYETHANOL
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM THIOSULFATE
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42192-150-02 57 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/21/2014
Labeler — Acella Pharmaceuticals, LLC (825380939)
Establishment
Name Address ID/FEI Operations
Acella Pharmaceuticals, LLC 825380939 manufacture (42192-150)

Revised: 01/2024 Acella Pharmaceuticals, LLC

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