SODIUM SULFACETAMIDE AND SULFUR solution

Sodium Sulfacetamide and Sulfur by

Drug Labeling and Warnings

Sodium Sulfacetamide and Sulfur by is a Prescription medication manufactured, distributed, or labeled by Seton Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx Only

DESCRIPTION:

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

Each mL of 10% Sodium Sulfacetamide 5% Sulfur Cleanser (in a Urea vehicle) contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in an emulsion base containing 10% Urea, butylated hydroxytoluene, cetyl alcohol, disodium EDTA, disodium oleamido MEA sulfosuccinate, fragrance, glyceryl stearate and PEG 100 stearate, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol and xanthan gum.

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:

10% Sodium Sulfacetamide 5% Sulfur Cleanser (in a Urea vehicle) is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS:

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

WARNINGS:

Rarely, 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. Use particular caution on areas of denuded or abraded skin.

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

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 10% Sodium Sulfacetamide 5% Sulfur Cleanser (in a Urea vehicle). It also is not known whether 10% Sodium Sulfacetamide 5% Sulfur Cleanser (in a Urea vehicle) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 10% Sodium Sulfacetamide 5% Sulfur Cleanser (in a Urea vehicle) 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 topical use of 10% Sodium Sulfacetamide 5% Sulfur Cleanser (in a Urea vehicle). However, small amounts of orally administered sulfonamides have been reported to be excreted in human milk. For this reason, and because many drugs are excreted in human milk, caution should be exercised when 10% Sodium Sulfacetamide 5% Sulfur Cleanser (in a Urea vehicle) is administered to a nursing woman.

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

ADVERSE REACTIONS:

Rarely, sodium sulfacetamide may cause local irritation.

DOSAGE AND ADMINISTRATION:

10% Sodium Sulfacetamide 5% Sulfur Cleanser (in a Urea vehicle). Wash affected area once or twice daily, or as directed by a physician. Avoid contact with eyes and mucous membranes. Wet skin and apply a generous amount to areas to be cleansed. Gently work into a full lather, massaging into the skin for 10-20 seconds. If drying of the skin occurs, it may be controlled by rinsing off the cleanser sooner or using less often.

HOW SUPPLIED:

10% Sodium Sulfacetamide 5% Sulfur Cleanser (in a Urea vehicle) is available in a 12 oz. (355 mL) bottle, NDC: 13925-161-12.

Store 10% Sodium Sulfacetamide 5% Sulfur Cleanser (in a Urea vehicle) at 15°-25° C (59°-77° F). 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 DRUGS OUT OF REACH OF CHILDREN

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:
Seton Pharmaceuticals
Manasquan, NJ 08736
1-800-510-3401
Iss. 5/11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 13925-161-12

10% SODIUM SULFACETAMIDE
5% SULFUR
CLEANSER
(in a Urea vehicle)

Rx Only

Indicated for the topical treatment of:
Acne Rosacea
Acne Vulgaris
Seborrheic Dermatitis

12 oz. (355 mL)

SETON

INGREDIENTS AND APPEARANCE

SODIUM SULFACETAMIDE AND SULFUR 
sodium sulfacetamide and sulfur solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 13925-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfacetamide (UNII: 4965G3J0F5) (Sulfacetamide - UNII:4965G3J0F5)	Sulfacetamide	100 mg  in 1 mL
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
UREA (UNII: 8W8T17847W)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DISODIUM OLEAMIDO MEA-SULFOSUCCINATE (UNII: 5M1101WGSY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
SODIUM THIOSULFATE (UNII: HX1032V43M)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13925-161-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/27/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/27/2011

Labeler - Seton Pharmaceuticals (828898002)