Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: This product is supplied in the following size(s): 8 fl. oz. (237 mL) bottles, NDC 16477-411-08; NDC 16477-411-08 RX ONLY SODIUM SULFACETAMIDE 10% Shampoo 8 fluid oz (237 mL) FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE LASER Manufactured for: Laser Pharmaceuticals, LLC Alpharetta, GA 30004 L-0411 Rev 0424-01 label
- HOW SUPPLIED: This product is supplied in the following size(s): 8 fl. oz. (237 mL) bottles, NDC 16477-411-08
- NDC 16477-411-08 RX ONLY SODIUM SULFACETAMIDE 10% Shampoo 8 fluid oz (237 mL) FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE LASER Manufactured for: Laser Pharmaceuticals, LLC Alpharetta, GA 30004 L-0411 Rev 0424-01 label
Overview
Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: cocamidopropyl betaine, edetate disodium, glycerin, hydroxypropyl methylcellulose, lactic acid, methylparaben, piroctone olamine, propylene glycol, purified water, sodium chloride, sodium laureth sulfate. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8H 9N 2NaO 3S•H2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether. formula
Indications & Usage
INDICATIONS: This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff).
Dosage & Administration
: Shake well before using. Apply to wet hair and massage vigorously into scalp. Rinse thoroughly. For best results, use at least twice a week or as directed by a doctor. Avoid contact with eyes or mucous membranes. Do not use on an infant less than 2 months of age.
Warnings & Precautions
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 of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
Contraindications
: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.
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 noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS ). To report a serious adverse event or obtain product information, call 1-844-302-5227.
Drug Interactions
. This product is incompatible with silver preparations.
Storage & Handling
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). 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.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.