FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
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.
Sodium sulfacetamide contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people (see CONTRAINDICATIONS section)."
FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
History
There is currently no drug history available for this drug.
Other Information
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:
Each gram of SE 10-5 SS (sodium sulfacetamide USP 10% and sulfur USP 5%) Cream contains: Active: Sodium Sulfacetamide 10% (100 mg) and Sulfur 5% (50 mg). Inactive: Benzyl Alcohol, Emulsifying Wax, Fragrance, Hamaelis virginiana (Witch Hazel) Distillate, Kaolin, Propanediol, Purified Water, Quillaja (Quillaia) saponaria Extract, Silicon Dioxide, Sodium Hydroxide, and Sodium Thiosulfate.
Sources
Se 10-5 Ss Manufacturers
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Seton Pharmaceuticals
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