Sulfacetamide Sodium 100 mg/mL Lotion, 118 mL — NDC 45802-896-26 (Billing 45802-0896-26)
This is a package of 118 mL of Sulfacetamide Sodium 100 mg/mL Lotion from Padagis Israel Pharmaceuticals Ltd, marketed since Oct 2012 and currently FDA-listed; retail pharmacies pay about $0.5150 per mL (NADAC). It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 041745
- GCN: 94446
- GPI-14 (Medi-Span): 90051036104120
- HICL (First Databank): 003345
- AHFS class code: 84:04.92.00
- RxCUI (RxNorm): 1006688
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Sulfonamide Antibacterial class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.515 | $60.77 / 118 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.6687 | $78.91 / 118 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.8429 | $99.46 / 118 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 45802-0896-26 You're viewing this Main listing | 118 mL in 1 BOTTLE, PLASTIC | 2012-10-17 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sulfacetamide Sodium 100 mg/mLthis 45802-0896-26 | Padagis | 118 ml | $0.515 | AB | Availability likely | — |
| Sodium sulfacetamide 100 mg/mL 68682-0010-04 | Oceanside | 1 bottle | $0.586 | AB | FDA listed | +14% |
| Klaron 100 mg/mL 00187-5198-04 | Bausch | 1 bottle | — | AB | FDA listed | — |
| Sulfacetamide Sodium 100 mg/mL 24470-0935-12 | Cintex | 355 ml | — | — | FDA listed | — |
| OVACE Plus 100 mg/mL 00178-0485-04 | Mission | 10 tubes | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII AZE05TDV2V
Diethanolamine is a chemical compound used in medicines as a pH adjuster and emulsifier. It helps balance acidity levels and allows oils and water-based ingredients to mix smoothly in liquid formulations.
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UNII 92RU3N3Y1O
Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
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UNII 9G34HU7RV0
EDTA is a chemical compound that binds to metals and other substances in medicines. It's used as a preservative and stabilizer to prevent discoloration and extend shelf life.
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UNII I29I2VHG38
A foaming and thickening agent derived from lauric acid (a natural fatty acid). It helps create texture and stability in liquid or semi-solid formulations, often used in topical products.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 4VON5FNS3C
Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
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UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
12 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is indicated in the topical treatment of acne vulgaris .
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Apply a thin film to affected areas twice daily.
⛔ Contraindications ▾
CONTRAINDICATIONS Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS section).
⚠️ Warnings ▾
WARNINGS Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity.
At the first sign of hypersensitivity, skin rash or other reactions, discontinue use of this preparation (see ADVERSE REACTIONS section). Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.
Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people (see CONTRAINDICATIONS section).
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In controlled clinical trials for the management of acne vulgaris, the occurrence of adverse reactions associated with the use of sulfacetamide sodium lotion was infrequent and restricted to local events. The total incidence of adverse reactions reported in these studies was less than 2%. Only one of 105 patients treated with sulfacetamide sodium lotion had adverse reactions of erythema, itching and edema.
It has been reported that sulfacetamide sodium may cause local irritation, stinging and burning. While the irritation may be transient, occasionally, the use of medication has to be discontinued.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects: Pregnancy Category C - Animal reproduction studies have not been conducted with Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion). It is also not known whether Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) should be given to a pregnant woman only if clearly needed.
Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well controlled studies of Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.
🧒 Pediatric Use ▾
Pediatric Use - Safety and effectiveness in pediatric patients under the age of 12 have not been established.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of paraminobenzoic acid (PABA) utilization, an essential component for bacterial growth. While absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. Sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged.
The biological half-life has been reported to be between 7 to 13 hours. The pharmacokinetics of sulfacetamide and its major metabolite sulfanilamide in sulfacetamide sodium lotion was evaluated in adult subjects (N=14) with acne vulgaris. The subjects applied sulfacetamide sodium lotion to their face, back, chest and shoulders every 12 hours for 28 days.
The percentage of the applied dose of sulfacetamide sodium lotion excreted in the urine as sulfacetamide plus sulfanilamide ranged from 0.08 to 0.33%.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is available as follows: 4 FL OZ (118mL) bottles (NDC 45802- 896 -26)
📦 Storage and Handling ▾
STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Shake well before using. Keep tightly closed.
📋 Description ▾
DESCRIPTION Each mL of Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) contains 100 mg of sulfacetamide sodium in a vehicle consisting of diethanolamine; EDTA; hydroxyethyl cellulose; lauramide DEA; methylparaben; polyethylene glycol 400, monolaurate; propylene glycol; purified water; simethicone; sodium chloride; sodium metabisulfite and xanthan gum. Sulfacetamide sodium is a sulfonamide with antibacterial activity. Chemically, sulfacetamide sodium is N'-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate.
The structural formula is: Image 1
⚠️ Precautions ▾
PRECAUTIONS General - For external use only. Keep away from eyes. If irritation develops, use of the product should be discontinued and appropriate therapy instituted.
Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Hypersensitivity reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. Sulfacetamide sodium can cause reddening and scaling of the skin.
Particular caution should be employed if areas of involved skin to be treated are denuded or abraded. Keep out of the reach of children. Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Pregnancy Teratogenic Effects: Pregnancy Category C - Animal reproduction studies have not been conducted with Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion). It is also not known whether Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) should be given to a pregnant woman only if clearly needed.
Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well controlled studies of Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. Nursing Mothers - It is not known whether sulfacetamide sodium is excreted in the human milk following topical use of Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion).
Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing women.
Pediatric Use - Safety and effectiveness in pediatric patients under the age of 12 have not been established.
🍼 Nursing Mothers ▾
Nursing Mothers - It is not known whether sulfacetamide sodium is excreted in the human milk following topical use of Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion). Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk.
Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing women.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies in animals have not been performed to evaluate carcinogenic potential.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 45802-896-26 Rx Only Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) For Topical Use Only Shake Well Before Using 4 FL OZ (118 mL) label