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Avar-e Green
sulfacetamide sodium, sulfur · Avar-e Green is a prescription drug containing sulfacetamide sodium, sulfur, made by Mission Pharmacal Company.
- Type
- Prescription
- Drug class
- Not classified
- Route
- Topical
- Manufacturers
- 1
This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Drug facts
- Generic name
- sulfacetamide sodium, sulfur
- Active ingredients
- Sulfacetamide Sodium, Sulfur
- Dosage forms
- Cream
- Label holder
- Mission Pharmacal Company
- Label updated
- 08/12/2025
Uses
This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
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.
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.
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.
Precautions
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. General: Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. 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. If the use of this product produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. 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. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas. Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. Information for Patients: Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. The use of this product also should be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop. Avoid contact with eyes, lips and mucous membranes. Drug Interactions: This product is incompatible with silver preparations. Pharmacology: Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed. Chromosomal nondisjunction has been reported in the yeast, Saccharomyces cerevisiae, following application of sodium sulfacetamide. The significance of this finding to the topical use of sodium sulfacetamide in the human is unknown. Pregnancy: Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus. Nursing Mothers: 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 this product is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children under the age of 12 years have not been established.
Side effects (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).
Overdose
The oral LD 50 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 or your doctor.
Description
Each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, chromium oxide green, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, 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.jpg
How supplied
This product is supplied in the following size(s): 2 oz. (57 g) bottles, NDC 0178-0460-02 To report a serious adverse event or obtain product information, call 1-800-298-1087. Manufactured for: MISSION PHARMACAL COMPANY San Antonio, TX 78230 1355
Storage and 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.
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Cream | 100 mg/g / 50 mg/g | topical | 1 |
Side effect reports to FDA
FDA Adverse Event Reporting System (FAERS), 114 reports that list sulfacetamide sodium, sulfur, data through 07/30/2026
Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.
Most often reported reactions
- Pain9
- Drug ineffective7
- Nausea7
- Anxiety5
- Erythema5
- Fall5
- Hypersensitivity5
- Rash5
- Rosacea5
- Dry skin4
To report a side effect, use FDA MedWatch.
Manufacturers and labels
1 FDA label
- Mission Pharmacal CompanyShown hereLabel 08/12/2025 · NDC 0178-0460Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing01/15/2025Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5...Jubilant Draximage Inc., dba Jubilant Radiopharma · Failed Stability Specifications
- Class IIIDrug05/15/2024Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela...Acella Pharmaceuticals, LLC · Subpotent drug
- Class IIDrug02/01/2023Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy...Pharmacy Innovations · Lack of Assurance of Sterility: FDA inspection revealed insanitary...
- Class IIIDrug12/07/2022Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g...Acella Pharmaceuticals, LLC · Subpotent drug: Out of specification for assay at the...
- Class IIDrug02/02/2022CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg /...Edge Pharma, LLC · 2 products · CGMP Deviations
Avar-e Green: common questions
- What is Avar-e Green used for?
- This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
- What are the side effects of Avar-e Green?
- Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. See the full side effects section on this page, and ask your doctor or pharmacist about any side effect that bothers you.
- Is Avar-e Green a prescription drug?
- Yes. Avar-e Green is a prescription (Rx) drug.
- Are there other products with the same active ingredient as Avar-e Green?
- Yes. Other FDA-listed products with the same active ingredients include Sulfacetamide Sodium, Sulfur, Plexion, Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser, Sodium Sulfacetamide and Sulfur.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 08/12/2025 · Label text is shown as published by the manufacturer. Not medical advice