The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Sodium Sulfacetamide (NDC 63629-9263). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding inactive ingredients, description, indications, contraindications, dosage and administration, warnings, storage, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Butylated Hydroxytoluene, Citric Acid, Cetyl Alcohol, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium Laureth Sulfate, Sodium Thiosulfate, Stearyl Alcohol, Triacetin, Xanthan Gum.
Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of:
Butylated Hydroxytoluene, Citric Acid, Cetyl Alcohol, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium Laureth Sulfate, Sodium Thiosulfate, Stearyl Alcohol, Triacetin, Xanthan Gum.
This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.
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.
Seborrheic dermatitis including seborrhea sicca - Wash affected areas twice daily (morning and evening) 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 working into a full lather, rinse thoroughly, pat dry and repeat after 10 to 20 seconds. Rinsing with plain water will remove any excess medication. Repeat application as described above for 8 to 10 days or as directed by your physician. lf skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently. Regular shampooing following the use of this product is not necessary, but the hair should be shampooed at least once a week. As the condition subsides, the interval between
applications may be lengthened. Applications once or twice weekly or every other week may prevent recurrence. Should the condition recur after stopping therapy, the application of this product should be reinitiated as at the beginning of treatment.
Secondary cutaneous bacterial infections - Wash affected areas twice daily (morning and evening) 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 to 20 seconds working into a full lather, rinse thoroughly and pat dry. Rinsing with plain water will remove any excess medication. Repeat application as described above for 8 to 10 days or as directed by your physician. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently. See package insert for full prescribing information.
WARNING: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
KEEP OUT OF REACH OF CHILDREN.
Avoid contact with eyes, lips and mucous membranes.
See label booklet for Full prescribing information.
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). Protect from freezing and excessive heat. Keep bottle tightly closed.
This bottle is not filled to the top but does contain 6 fl oz of product as identified on the front
panel of the bottle.
To report a serious adverse event or obtain product information, call (877) 250-3427.
NDC: 63629-9263-1: 355 g Liquid in a BOTTLE
Sodium Sulfacetamide 10% #355
Label (Lbl636299263)
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