SODIUM SULFACETAMIDE 10% WASH

(sodium sulfacetamide 10%)

RX Only

FOR EXTERNAL USE ONLY.

NOT FOR OPHTHALMIC USE.

Each mL contains 100 mg of sodium sulfacetamide USP in a vehicle consisting of: ammonium lauryl sulfate, butylated hydroxytoluene, ceteareth-25, cetyl alcohol, cocamidopropyl betaine, disodium EDTA, glycerin, guar gum, methylparaben, propylene glycol, propylparaben, purified water, sodium thiosulfate, stearyl alcohol, triacetin.

Chemically, it is Acetamide N-[4-aminophenyl)sulfonyl]-,monosodium salt, monohydrate, with the following structural formula:

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.

Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There is no clinical data available on the degree and rate of systemic competition with para-aminobenzoic acid absorption of Sodium Sulfacetamide 10% Wash when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported. The following in vitro data are available but their clinical significance is unknown. Organisms which show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris,

Nocardia and Actinomyces.

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 of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

Sodium Sulfacetamide 10% Wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.

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 out of the reach of children.

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 a sulfonamide is readministered, irrespective of the route of administration, and cross hypersensitivity between different sulfonamides may occur. If Sodium Sulfacetamide 10% 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.

Patients should discontinue Sodium Sulfacetamide 10% Wash if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. Sodium Sulfacetamide 10% Wash also should be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop.

Sodium Sulfacetamide 10% Wash is incompatible with silver preparations.

Sodium Sulfacetamide 10% Wash has a bacteriostatic effect against Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections.

Long-term animal studies for carcinogenic potential have not been performed on Sodium Sulfacetamide 10% Wash to date. Studies on reproduction and fertility also have not been performed. Chromosomal nondisjunction in the yeast, Saccharomyces cerevisiae, following application of sodium sulfacetamide has been reported. The significance of this finding to the topical use of sodium sulfacetamide in the human is unknown.

Category C: Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% Wash. It also is not known whether Sodium Sulfacetamide 10% Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% Wash should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

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 Sodium Sulfacetamide 10% Wash is administered to a nursing woman.

Safety and effectiveness in children under the age of 12 years have not been established.

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).

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The oral LD50 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. Large oral overdosage may cause hematuria, crystalluria, and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. For treatment, contact your local Poison Control Center.

Seborrheic dermatitis including seborrhea sicca - Sodium Sulfacetamide 10% Wash: 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 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 Sodium Sulfacetamide 10% 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 Sodium Sulfacetamide 10% 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 for 10-20 seconds working into a full lather, rinse thoroughly and pat dry. Rinsing with plain water will remove any excess medication. Repeat application as described for eight to ten days. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less often.

Sodium Sulfacetamide Wash 10% is available in a 6 fl. oz (170 mL) bottle, NDC 69437-410-06, and in a 12 oz (354.8 mL) bottle, NDC 69437-410-12.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). See USP Controlled Room Temperature. Protect from freezing.

Note: Store upright. 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 wash 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.

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 has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein.

Manufactured in the U.S.A. for:

Canton Laboratories, LLC

Alpharetta, GA 30004

Rev. 09/21

INDICATIONS: 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 of secondary bacterial infections of

the skin due to organisms susceptible to sulfonamides.

DIRECTIONS FOR USE: Wash affected areas twice daily (morning and evening) or as directed by your physician. Rinse

thoroughly and pat dry. See label booklet for complete product information.

FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR OPHTHALMIC USE. (KEEP AWAY FROM EYES)

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. In case of accidental ingestion contact a poison control center immediately. Keep container tightly closed.

CONTRAINDICATIONS: Sodium Sulfacetamide 10% Wash is contraindicated in persons with known or suspected

hypersensitivity to sulfonamides.

Each mL contains 100 mg of sodium sulfacetamide USP in a vehicle consisting of: ammonium lauryl sulfate, butylated

hydroxytoluene, ceteareth-25, cetyl alcohol, cocamidopropyl betaine, disodium EDTA, glycerin, guar gum, methylparaben,

propylene glycol, propylparaben, purified water, sodium thiosulfate, stearyl alcohol, triacetin.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). See USP Controlled Room. Protect from freezing. See bottle for lot number and expiration date.

Important Note:

This bottle is not filled to the top but does contain 12 fl oz of product as identified on the front panel of the bottle.

NDC 69437-410-12

Rx Only

For External Use Only

Sodium Sulfacetamide 10% Wash

12 FL OZ (354.8 mL)

Manufactured in the U.S.A. for

Canton Laboratories, LLC

Alpharetta, GA 30004