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Sodium Sulfacetamide and Sulfur Cream

Dosage Form: cream

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.

NDC 42494-333-02

Rx Only

FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.

Sodium Sulfacetamide and Sulfur Cream Description

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

Each gram of Sulfacetamide Sodium-Sulfur 10-2% External Cream contains 100 mg of sulfacetamide sodium and 20 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum.

Sodium Sulfacetamide and Sulfur Cream - 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, sodium sulfacetamide 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 unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

INDICATIONS

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

Contraindications

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

Warnings

Although 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.

Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome.

KEEP OUT OF REACH OF CHILDREN.

PRECAUTIONS:

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

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.
Avoid contact with eyes or mucous membranes.

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

Nursing Mothers

It is not known whether sodium sulfacetamide is excreted in human milk following topicaI use of Sulfacetamide Sodium-Sulfur 10-2% External Cream However, small amounts of orally administered sulfonamides have been reported to be excreted in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sulfacetamide Sodium-Sulfur 10-2% External Cream is administered to a nursing woman.

Pediatric Use

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

Adverse Reactions

Although rare, sodium sulfacetamide may cause local irritation. Call your licensed medical practitioner for medical advice about side effects. To report a serious adverse event, call 1-888-767-7913..

Sodium Sulfacetamide and Sulfur Cream Dosage and Administration

Wash hands. Cleanse affected area. Apply a thin layer 1 to 3 times daily or as directed by a licensed medical practitioner. Massage the cream completely and uniformly into the skin. Avoid contact with eyes or mucous membranes.

How is Sodium Sulfacetamide and Sulfur Cream Supplied

Sulfacetamide Sodium-Sulfur 10-2% External Cream is supplied in an 2 oz (57 g) bottle, NDC 42494-333-02.

STORAGE:

Store at controlled room temperature 20°C - 25°C (68°F -77°F); excursions permitted to between 15°C to 30°C (59°F to 86°F).

Protect from freezing and excessive heat. Keep container tightly closed.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product has not been evaluated for therapeutic equivalence.


KEEP OUT OF REACH OF CHILDREN
Rx Only

Manufactured for:

Cameron Pharmaceuticals, LLC
Frankfort, Kentucky 40601
Rev. 2/2015

PRINCIPAL DISPLAY PANEL - 57 g Bottle Label

NDC 42494-333-02
Rx Only

Sulfacetamide Sodium-
Sulfur 10-2%
External Cream

WARNINGS: FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.

Cameron Pharmaceuticals

Net Wt. 2 oz (57 g)

SODIUM SULFACETAMIDE AND SULFUR EXTERNAL CREAM 
sulfacetamide sodium and sulfur cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42494-333
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
BENZYL ALCOHOL  
CETYL ALCOHOL  
EDETATE DISODIUM  
GLYCERYL MONOSTEARATE  
PEG-100 STEARATE  
MAGNESIUM ALUMINUM SILICATE  
PEG-150 DISTEARATE  
PHENOXYETHANOL  
POLYETHYLENE GLYCOL 400  
WATER  
SODIUM LAURYL SULFATE  
SODIUM THIOSULFATE  
STEARYL ALCOHOL  
XANTHAN GUM  
Packaging
# Item Code Package Description
1 NDC:42494-333-02 57 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 10/26/2015
Labeler - Cameron Pharmaceuticals, LLC (078371442)
Registrant - Cameron Pharmaceuticals, LLC (078371442)
Revised: 10/2015
 
Cameron Pharmaceuticals, LLC
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