Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. NOTICE: Protect from freezing and excessive heat. The product may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product. Keep bottle tightly closed. Occasionally, a slight discoloration of fabric may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily removed by ordinary laundering without bleaches. This bottle is not filled to the top but does contain 16 fl oz of product as identified on the front panel of the bottle. Manufactured for and distributed by: Gabar Health Sciences Corp. 1 Hartsfield Center Parkway Atlanta, GA 30354; image description
- HOW SUPPLIED Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. NOTICE: Protect from freezing and excessive heat. The product may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product. Keep bottle tightly closed. Occasionally, a slight discoloration of fabric may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily removed by ordinary laundering without bleaches. This bottle is not filled to the top but does contain 16 fl oz of product as identified on the front panel of the bottle. Manufactured for and distributed by: Gabar Health Sciences Corp. 1 Hartsfield Center Parkway Atlanta, GA 30354
- image description
Overview
Each gram of sodium sulfacetamide 9% and sulfur 4% cleanser contains 90 mg of sodium sulfacetamide and 40 mg of sulfur in a cleanser containing 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. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8 H 9 N 2 NaO 3 S·H 2 O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: image description
Indications & Usage
INDICATIONS: SODIUM SULFACETAMIDE 9% - SULFUR 4% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage & Administration
Wash affected area once or twice daily, or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing cleanser off sooner or using less often. See label booklet for Full Prescribing Information.
Warnings & Precautions
WARNING 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. FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR OPHTHALMIC USE. (KEEP AWAY FROM EYES). KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion contact a poison control center immediately. Keepcontainer tightly closed.
Contraindications
: SODIUM SULFACETAMIDE 9% - SULFUR 4% CLEANSER is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SODIUM SULFACETAMIDE 9% - SULFUR 4% CLEANSER is not to be used by patients with kidney disease.
Adverse Reactions
Adverse Reaction Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects. To report a serious adverse event or obtain product information, call 1-470-737-9424.
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