Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: 6 oz. (170.3 g) bottles, NDC 52187-536-06 12 oz. (340.2 g) bottles, NDC 52187-536-12 To report a serious adverse event or obtain product information, call 1-855-899-4237. Manufactured for: KMM Pharmaceuticals, LLC 1000 N. West Street Suite 1200, #1021 Wilmington, DE 19801 2000228 [00] Rev. 10/2020; label1 label2
- HOW SUPPLIED: 6 oz. (170.3 g) bottles, NDC 52187-536-06 12 oz. (340.2 g) bottles, NDC 52187-536-12 To report a serious adverse event or obtain product information, call 1-855-899-4237. Manufactured for: KMM Pharmaceuticals, LLC 1000 N. West Street Suite 1200, #1021 Wilmington, DE 19801 2000228 [00] Rev. 10/2020
- label1 label2
Overview
Each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, phenoxyethanol, propylene glycol, purified water, sodium lauryl sulfate, sodium lithium magnesium silicate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8 H 9 N 2 NaO 3 S·H 2 O 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. structure
Indications & Usage
INDICATIONS: This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage & Administration
: Wash affected areas once or twice daily, or as directed by your physician. 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 skin dryness occurs, it may be controlled by rinsing product off sooner or using less frequently.
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 OUT OF 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).
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.
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