SODIUM SULFACETAMIDE 100 mg/mL
SODIUM SULFACETAMIDE · LIQUID · Acella Pharmaceuticals, LLC
SODIUM SULFACETAMIDE is a liquid containing sodium sulfacetamide at 100 mg/mL, taken topical. Manufactured by Acella Pharmaceuticals, LLC.
Key Facts
- Brand Name
- SODIUM SULFACETAMIDE
- Generic Name
- SODIUM SULFACETAMIDE
- NDC Code (Product)
42192-129- Manufacturer
- Acella Pharmaceuticals, LLC
- Strength
- 100 mg/mL
- Dosage Form
- LIQUID
- Route
- TOPICAL
- Marketing Status
- Marketing Start
- 01/04/2011
Recall History
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Acella Pharmaceuticals, LLC
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Mission Pharmacal Co
Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mission Pharmacal Co
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Monarch PCM, LLC
Subpotency: one product for active ingredient assay and another one for preservative assay
Mission Pharmacal Co
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Acella Pharmaceuticals, LLC
Subpotent drug
Full Prescribing Information
Indications & Usage
INDICATIONS: This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage & Administration
DOSAGE AND ADMINISTRATION: Cleanse affected areas. Apply a thin layer to the affected areas with light massaging, 1 to 3 times daily or as directed by a physician.
Warnings
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 THE REACH OF CHILDREN.
Contraindications
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
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).
Frequently Asked Questions
What is SODIUM SULFACETAMIDE used for?
SODIUM SULFACETAMIDE contains SODIUM SULFACETAMIDE. It is a liquid taken topical. Consult your doctor for specific uses.
Is SODIUM SULFACETAMIDE a controlled substance?
SODIUM SULFACETAMIDE is not classified as a controlled substance by the DEA.
What is the generic name for SODIUM SULFACETAMIDE?
The generic name for SODIUM SULFACETAMIDE is SODIUM SULFACETAMIDE. There are 10 other brand versions of SODIUM SULFACETAMIDE.
What is the NDC code for SODIUM SULFACETAMIDE 100 mg/mL?
The NDC (National Drug Code) for SODIUM SULFACETAMIDE 100 mg/mL is 42192-129, listed by Acella Pharmaceuticals, LLC.
Other SODIUM SULFACETAMIDE Dosages
Other Sodium Brands
See all →- SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream100 mg/g72162-2246
- Sodium Sulfacetamide 10% and Sulfur 5% Cleanser100 mg/g83720-547
- SODIUM SULFACETAMIDE, SULFUR90 mg/mL24470-950
- Sodium Sulfacetamide and Sulfur80 mg/mL42192-133
- Sodium Sulfacetamide100 mg/g58657-477
- Sodium Sulfacetamide100 mg/g63629-9263
- Sodium Sulfacetamide100 mg/mL16477-411
- Sodium Sulfacetamide 8% Sulfur 4% CLEANSER80 mg/mL83720-542
- Sodium Sulfacetamide 10% wash100 mg/mL83720-543
- OVACE PLUS100 mg/mL0178-0630
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)