Data from FDA - Curated by EPG Health - Last updated 09 October 2017

Indication(s)

INDICATIONS AND USAGE SEB-Prev™ Wash 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.

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Advisory information

contraindications
CONTRAINDICATIONS SEB-Prev™ Wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.
Special warnings and precautions
PRECAUTIONS General - Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration, and cross hypersensitivity between different sulfonamides may occur. If SEB-Prev™ Wash produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded, or severely burned areas. Under these circumstances, potentially any of the adverse effects produced by the systemic administration of these agents could occur and appropriate observations and laboratory determinations should be performed. Information For Patients - Patients should discontinue SEB-Prev™ Wash if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. SEB-Prev™ Wash also should be discontinued promptly and the physician notified if any arthritis, fever, or sores in the mouth develop. For external use only. Avoid contact with eyes and mucous membranes. Keep this and all medications out of reach of children. In case of accidental ingestion, call a physician or poison control center immediately (see OVERDOSAGE). Drug Interactions - SEB-Prev™ Wash is incompatible with silver preparations. Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term animal studies for carcinogenic potential have not been performed on SEB-Prev™ Wash to date. Studies on reproduction and fertility also have not been performed. One author detected chromosomal nondisjunction in the yeast, Saccharomyces cerevisiae, following application of sulfacetamide sodium. The significance of this finding to the topical use of sulfacetamide sodium in the human is unknown. Pregnancy: Teratogenic effects: Pregnancy Category C - Animal reproduction studies have not been conducted with SEB-Prev™ Wash. It also is not known whether SEB-Prev™ Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SEB-Prev™ Wash should be given to a pregnant woman only if clearly needed. 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 SEB-Prev™ Wash is administered to a nursing woman. Pediatric Use - Safety and effectiveness in children under the age of 12 years have not been established.
Adverse reactions
ADVERSE REACTIONS Reports of irritation and hypersensitivity to sulfacetamide sodium are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sulfacetamide sodium, 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 has been reported (see WARNINGS).

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION 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 and pat dry. Rinsing with plain water will remove any excess medication. Repeat application as described for eight to ten days. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently. Regular shampooing following SEB-Prev™ Wash 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 SEB-Prev™ Wash should be reinitiated as at the beginning of treatment. Secondary cutaneous bacterial infections: Wet skin and liberally apply to areas to be cleansed, massage gently into skin working into a full lather, rinse thoroughly and pat dry. Rinsing with plain water will remove any excess medication. Repeat application as described for eight to ten days. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less often.
Pregnancy and lactation
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 SEB-Prev™ Wash is administered to a nursing woman.

Interactions

Drug Interactions - SEB-Prev™ Wash is incompatible with silver preparations.

More information

Category Value
Agency product number 4NRT660KJQ
Orphan designation No
Product NDC 45802-939
Date Last Revised 25-09-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 1006114
Storage and handling Click here to enter text. Store upright at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect from freezing and excessive heat. The wash may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product. Occasionally, a slight yellowish discoloration may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration is readily removed by ordinary laundering without bleaches.
Marketing authorisation holder Perrigo New York Inc