FDA records indicate that there are no current recalls for this drug.
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Sodium Sulfacetamide And Sulfur Kit Recall
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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.
FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children.
Keep bottle tightly closed.
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 nonasthmatic people.
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
Sodium Sulfacetamide 10% and Sulfur 5% Lotion 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
Each mL of Sodium Sulfacetamide 10% and Sulfur 5% Lotion as dispensed contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a tinted lotion of 2-bromo-2-nitropropane-1,3-diol, butylparaben, colloidal activated attapulgite, diethanolamine, hydroxyethyl cellulose, iron oxides, lauramide DEA, methylparaben, polyethylene glycol 400 monolaurate, propylene glycol, purified water, simethicone emulsion, sodium chloride, sodium metabisulfite, sodium polynaphthalenesulfonate, talc, titanium dioxide, xanthan gum, and zinc oxide. Color Tinter contains an additional inactive ingredient, polyethylene glycol 400.
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:
Sources
Sodium Sulfacetamide And Sulfur Kit Manufacturers
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Perrigo New York Inc
Sodium Sulfacetamide And Sulfur Kit | Perrigo New York Inc
Shake well before using. Apply a thin film to affected areas with light massaging to blend in each application 1 to 3 times daily, or as directed by a physician. Each package contains a color tinter which enables the patient to alter the basic shade of the lotion so that it matches the skin color exactly.
(Important to the Pharmacist: At the time of dispensing, add contents of sodium sulfacetamide vial* to the bottle. Shake well and/or stir with a glass rod to insure uniform dispersion. Place expiration date of four (4) months on bottle label.)
*Sodium Sulfacetamide vial contains 2.1 g of sodium sulfacetamide.
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