Label: SODIUM SULFACETAMIDE liquid

  • NDC Code(s): 16477-410-06, 16477-410-12
  • Packager: Laser Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated April 23, 2025

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  • Description:
    Each mL contains 100 mg of sodium sulfacetamide in a vehicle consisting of: citric acid, cocamidopropyl betaine, edetate disodium, glycerin, glyceryl stearate, methylparaben, PEG-6 caprylic/capric ...
  • CLINICAL PHARMACOLOGY:
    Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It ...
  • INDICATIONS AND USAGE:
    Sodium Sulfacetamide 10% Wash is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment ...
  • CONTRAINDICATIONS:
    Sodium Sulfacetamide 10% Wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.
  • WARNINGS:
    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 ...
  • PRECAUTIONS:
    For external use only. Not for ophthalmic use. General: Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Hypersensitivity reactions may recur when ...
  • Information For Patients:
    Patients should discontinue the use of Sodium Sulfacetamide 10% Wash if the condition becomes worse or if a rash develops in the area being treated or elsewhere. The use of Sodium Sulfacetamide ...
  • Drug Interactions:
    Sodium Sulfacetamide 10% Wash is incompatible with silver preparations.
  • Pharmacology:
    Sodium Sulfacetamide 10% Wash has a bacteriostatic effect against Gram-positive and Gram-negative miroorganisms commonly isolated from secondary cutaneous pyogenic infections.
  • Carcinogenesis, Mutagenesis and Impairment of Fertility:
    Long-term animal studies for carcinogenic potential have not been performed on Sodium Sulfacetamide 10% Wash to date. Studies on reprodution and fertility also have not been performed. Chromosomal ...
  • Pregnancy: Category C:
    Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% Wash. It is also not known whether Sodium Sulfacetamide 10% Wash can affect reproduction capacity or cause fetal ...
  • Nursing Mothers:
    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
  • Pediatric Use:
    Safety and effectiveness in chlidren under the age of 12 years have not ben established.
  • ADVERSE REACTIONS
    Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are ...
  • OVERDOSAGE:
    The oral LD - 50 of sulfacetamide in mice is 16.5 g/kg. In the event of overdosage, emergency treatment should be started immediately. Manifestations: Overdosage may cause nausea and vomiting ...
  • DOSAGE AND ADMINISTRATION:
    Seborrheic dermatits including seborrhea sica - Sodium Sulfacetamide 10% Wash: Wash affected areas twice daily (morning and evening), or as directed by your phyiscian. Avoid contact with eyes or ...
  • HOW SUPPLIED:
    Sodium Sulfacetamide 10% Wash is supplied in the following size(s): 6 fl. oz. (177 mL) bottle, NDC 16477-410-06, and 12 fl. oz (354.8mL) bottle, NDC 16477-410-12
  • STORAGE:
    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). See USP Controlled Room Temperature. Protect from freezing. NOTICE: Store upright ...
  • SPL UNCLASSIFIED SECTION
    All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and ...
  • PRINCIPAL DISPLAY PANEL
    NDC 16477-410-06 - Rx Only - For External Use Only - Sodium - Sulfacetamide - 10% Wash - LASER Pharmaceuticals, LLC - 6 fl oz (177 mL) INGREDIENTS: Each mL of Sodium Sulfacetamide 10% Wash contains ...
  • INGREDIENTS AND APPEARANCE
    Product Information