Sulfacetamide Sodium 100 mg/mL
sulfacetamide sodium · SOLUTION/ DROPS · Bausch & Lomb Incorporated
Sulfacetamide sodium is a prescription antibiotic eye drop used to treat bacterial eye infections. It works by stopping the growth of bacteria that cause conditions like conjunctivitis and other eye infections.
Key Facts
- Brand Name
- Sulfacetamide Sodium
- Generic Name
- sulfacetamide sodium
- NDC Code (Product)
24208-670- Manufacturer
- Bausch & Lomb Incorporated
- Strength
- 100 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA040066
- Marketing Start
- 12/28/1994
Recall History
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Allergan Sales, LLC
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Allergan Sales, LLC
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Altaire Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Edge Pharma, LLC
CGMP Deviations
Edge Pharma, LLC
CGMP Deviations
Akorn, Inc.
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
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: 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
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
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 Sulfacetamide Sodium used for?
Sulfacetamide sodium is a prescription antibiotic eye drop used to treat bacterial eye infections. It works by stopping the growth of bacteria that cause conditions like conjunctivitis and other eye infections.
Is Sulfacetamide Sodium a controlled substance?
Sulfacetamide Sodium is not classified as a controlled substance by the DEA.
What is the generic name for Sulfacetamide Sodium?
The generic name for Sulfacetamide Sodium is sulfacetamide sodium. There are 10 other brand versions of sulfacetamide sodium.
What is the NDC code for Sulfacetamide Sodium 100 mg/mL?
The NDC (National Drug Code) for Sulfacetamide Sodium 100 mg/mL is 24208-670, listed by Bausch & Lomb Incorporated.
Other Sulfacetamide Sodium Dosages
Other Sulfacetamide Brands
See all →- Sumaxin CP43538-101
- Sodium Sulfacetamide, Sulfur100 mg/g44523-520
- SODIUM SULFACETAMIDE, SULFUR100 mg/g44523-604
- OVACE Plus100 mg/mL0178-0485
- SULFACETAMIDE SODIUM98 mg/mL52187-553
- Sodium Sulfacetamide 10 Sulfur 5 Cleanser10 mg/g42192-136
- Plexion98 mg/g44118-700
- Avar-e Green100 mg/g0178-0460
- SODIUM SULFACETAMIDE AND SULFUR100 mg/g44523-602
- SODIUM SULFACETAMIDE AND SULFUR100 mg/g44523-603
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)