Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED SODIUM SULFACETAMIDE 10% - SULFUR 5% CLEANSER is supplied in a 6 oz. (170.3 g) bottle, NDC 71399-0488-6.; label
- HOW SUPPLIED SODIUM SULFACETAMIDE 10% - SULFUR 5% CLEANSER is supplied in a 6 oz. (170.3 g) bottle, NDC 71399-0488-6.
- label
Overview
Each mL of Sodium Sulfacetamide 10% - Sulfur 5% Cleanser contains 100 mg of Sodium Sulfacetamide and 50 mg of Sulfur in a formulation containing aloe vera gel, cocamidopropyl betaine, cocamide dea, cetyl alcohol, disodium edetate, glyceryl monostearate, methylparaben, PEG-40 stearate, polyethylene glycol-60, propylene glycol, purified water, sodium chloride, sodium lauryl sulfate, sodium metabisulfite, sodium thiosulfate and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: struct
Indications & Usage
INDICATIONS SODIUM SULFACETAMIDE 10% - SULFUR 5% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage & Administration
Wash affected areas with SODIUM SULFACETAMIDE 10% - SULFUR 5% CLEANSER 1 to 2 times daily or as directed by a 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. If drying occurs, it may be controlled by rinsing cleanser off sooner or using cleanser less often.
Warnings & Precautions
WARNINGS Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved. 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 REACH OF CHILDREN.
Contraindications
: SODIUM SULFACETAMIDE 10% - SULFUR 5% CLEANSER is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SODIUM SULFACETAMIDE 10% - SULFUR 5% CLEANSER is not to be used by patients with kidney disease.
Adverse Reactions
Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects.
Storage & Handling
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP “Controlled Room Temperature.”] Note: 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 container or packet tightly closed. 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, 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 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 recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein. QUESTIONS? Please Call 1(877) 225-6999 Manufactured for: Akron Pharma, Inc. Fairfield, NJ 07004 Manufactured in U.S.A
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