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Sulfur and sulfacetamide: Drug information

Sulfur and sulfacetamide: Drug information
(For additional information see "Sulfur and sulfacetamide: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • AVAR;
  • AVAR LS;
  • AVAR-e;
  • AVAR-e Green;
  • AVAR-e LS;
  • BP 10-1;
  • BP Cleansing Wash;
  • Clarifoam EF [DSC];
  • Clenia Plus;
  • Clenia [DSC];
  • Plexion;
  • Prascion [DSC];
  • Rosanil [DSC];
  • Rosula Wash [DSC];
  • Rosula [DSC];
  • SSS 10-5;
  • SulfaCleanse 8/4;
  • Sulfamez Wash;
  • Sumadan;
  • Sumadan XLT;
  • Sumaxin;
  • Virti-sulf [DSC];
  • Zma Clear
Brand Names: Canada
  • Sulfacet-R
Pharmacologic Category
  • Acne Products;
  • Antibiotic, Sulfonamide Derivative;
  • Antiseborrheic Agent, Topical;
  • Topical Skin Product, Acne
Dosing: Adult
Acne vulgaris, acne rosacea, seborrheic dermatitis

Acne vulgaris, acne rosacea, seborrheic dermatitis:

Cream, lotion, emollient cream: Apply a thin film to affected area 1 to 3 times daily.

Cleanser, cleansing cloth/pads: Wash affected area 1 to 2 times daily.

Emollient foam: Apply to affected area 1 to 2 times daily; foam may remain on skin or may be rinsed off after 1 to 2 minutes.

Suspension: Apply to affected area 1 to 2 times daily.

Dosing: Kidney Impairment: Adult

Use is contraindicated.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric
Acne vulgaris, acne rosacea, seborrheic dermatitis

Acne vulgaris, acne rosacea, seborrheic dermatitis: Children ≥12 years and Adolescents: Refer to adult dosing.

Dosing: Kidney Impairment: Pediatric

Use is contraindicated.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see Sulfacetamide (Topical).

Frequency not defined: Dermatologic: Desquamation, erythema of skin, pruritus, skin irritation, xeroderma

Contraindications

Hypersensitivity to sulfur, sulfonamides, or any component of the formulation; renal disease

Note: Although the FDA-approved product labeling states this medication is contraindicated in patients with hypersensitivity to sulfonamide-containing drugs, the scientific basis of this cross-sensitivity has been challenged. See “Warnings/Precautions” for more detail.

Warnings/Precautions

Concerns related to adverse effects:

• Autoimmune diseases: Fatalities associated with severe reactions, including drug-induced systemic lupus erythematosus, have occurred with sulfonamides (regardless of administration route).

• Blood dyscrasias: Fatalities associated with severe reactions, including agranulocytosis, acute hemolytic anemia, aplastic anemia, purpura hemorrhagica, and other blood dyscrasias, have occurred with sulfonamides (regardless of route).

• Dermatologic reactions: Fatalities associated with severe reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug fever, have occurred with sulfonamides (regardless of route). In addition, contact dermatitis, reddening, and scaling of the skin may occur.

• Hepatic effects: Fatalities associated with severe reactions, including fulminant hepatic necrosis and jaundice, have occurred with sulfonamides (regardless of route).

• Hypersensitivity reactions: Skin rash or other reactions have occurred in patients with no prior history of sulfonamide hypersensitivity. Discontinue use at the first sign of hypersensitivity or rash.

• Sulfonamide ("sulfa") allergy: Traditionally, concerns for cross-reactivity have extended to all compounds containing the sulfonamide structure (SO2NH2). An expanded understanding of allergic mechanisms indicates cross-reactivity between antibiotic sulfonamides and nonantibiotic sulfonamides may not occur, or at the very least this potential is extremely low (Brackett 2004; Johnson 2005; Slatore 2004; Tornero 2004). In particular, mechanisms of cross-reaction due to antibody production (anaphylaxis) are unlikely to occur with nonantibiotic sulfonamides and antibiotic sulfonamides. A nonantibiotic sulfonamide compound which contains the arylamine structure and therefore may cross-react with antibiotic sulfonamides is sulfasalazine (Zawodniak 2010). T-cell-mediated (type IV) reactions (eg, maculopapular rash) are less understood and it is not possible to completely exclude this potential based on current insights. In cases where prior reactions were severe (Stevens-Johnson syndrome/TEN), some clinicians choose to avoid exposure to these classes.

• Systemic effects: Systemic absorption is increased with application to large, infected, abraded, denuded, or burned skin.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.

Other warnings/precautions:

• Appropriate use: For external use only; avoid contact with eyes, eyelids, lips, and mucous membranes. Use with caution if areas of denuded or abraded skin are involved. Discontinue use if irritation, rash, or signs of hypersensitivity occur.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cleanser, topical:

AVAR: Sulfur 5% and sulfacetamide sodium 10% (227 g) [contains benzyl alcohol]

AVAR LS: Sulfur 2% and sulfacetamide sodium 10% (227 g) [contains benzyl alcohol]

Plexion: Sulfur 4.8% and sulfacetamide sodium 9.8% (285 g) [contains benzyl alcohol]

Prascion: Sulfur 5% and sulfacetamide sodium 10% (170 g [DSC])

Rosanil: Sulfur 5% and sulfacetamide sodium 10% (170 g [DSC])

Generic: Sulfur 2% and sulfacetamide sodium 10% (227 g); Sulfur 4.8% and sulfacetamide sodium 9.8% (285 g); Sulfur 5% and sulfacetamide sodium 10% (170 g, 227 g, 340 g)

Cream, topical:

AVAR-e: Sulfur 5% and sulfacetamide sodium 10% (45 g [DSC], 57 g) [contains benzyl alcohol]

AVAR-e Green: Sulfur 5% and sulfacetamide sodium 10% (45 g [DSC], 57 g) [contains benzyl alcohol; color corrective cream]

AVAR-e LS: Sulfur 2% and sulfacetamide sodium 10% (45 g [DSC], 57 g) [contains benzyl alcohol]

Clenia: Sulfur 5% and sulfacetamide sodium 10% (28 g) [DSC]

Plexion: Sulfur 4.8% and sulfacetamide sodium 9.8% (57 g) [contains benzyl alcohol]

SSS 10-5: Sulfur 5% and sulfacetamide sodium 10% (28 g)

Virti-sulf: Sulfur 5% and sulfacetamide sodium 10% (28 g) [DSC]

Generic: Sulfur 2% and sulfacetamide sodium 10% (57 g); Sulfur 4.8% and sulfacetamide sodium 9.8% (57 g); Sulfur 5% and sulfacetamide sodium 10% (28 g, 57 g)

Foam, topical:

Clarifoam EF: Sulfur 5% and sulfacetamide sodium 10% (60 g [DSC], 100 g [DSC])

SSS 10-5: Sulfur 5% and sulfacetamide sodium 10% (60 g, 100 g)

Generic: Sulfur 5% and sulfacetamide sodium 10% (60 g)

Lotion, topical:

Plexion: Sulfur 4.8% and sulfacetamide sodium 9.8% (57 g) [contains benzyl alcohol]

Generic: Sulfur 4.8% and sulfacetamide sodium 9.8% (57 g)

Pad, topical [cleansing cloth]:

Plexion: Sulfur 4.8% and sulfacetamide sodium 9.8% (60s) [contains benzyl alcohol]

Rosula: Sulfur 5% and sulfacetamide sodium 10% (30s [DSC], 60s [DSC])

Sumaxin: Sulfur 4% and sulfacetamide sodium 10% (60s) [contains aloe]

Generic: Sulfur 4.8% and sulfacetamide sodium 9.8% (60s), Sulfur 4% and sulfacetamide sodium 10% (60s [DSC])

Suspension, topical:

Clenia Plus: Sulfur 4.25% and sulfacetamide sodium 9% (30 mL, 237 mL) [contains aloe]

SulfaCleanse 8/4: Sulfur 4% and sulfacetamide sodium 8% (473 mL) [contains aloe]

Zma Clear: Sulfur 4.5% and sulfacetamide sodium 9% (237 mL) [contains aloe]

Generic: Sulfur 4% and sulfacetamide sodium 8% (473 mL); Sulfur 5% and sulfacetamide sodium10% (30 g)

Wash, topical:

BP 10-1: Sulfur 1% and sulfacetamide sodium 10% (170 g)

BP Cleansing Wash: Sulfur 5% and sulfacetamide sodium 10% (480 mL) [contains urea]

Rosula Wash: Sulfur 4.5% and sulfacetamide sodium 10% (340.2 g [DSC])

Sulfamez Wash: Sulfur 1% and sulfacetamide sodium 10% (177 mL)

Sumaxin: Sulfur 4% and sulfacetamide sodium 9% (473 mL) [contains aloe]

Generic: Sulfur 4% and sulfacetamide sodium 9% (480 mL)

Wash, topical [emulsion-based]:

BP Cleansing Wash: Sulfur 4% and sulfacetamide sodium 10% (473 mL) [contains urea]

Sumadan: Sulfur 4.5% and sulfacetamide sodium 9% (454 g)

Sumadan XLT: Sulfur 4.5% and sulfacetamide sodium 9% (454 g) [packaged in a kit with Niseko sunscreen SPF 25]

Generic: Sulfur 4.5% and sulfacetamide sodium 9% (454 g); Sulfur 5% and sulfacetamide sodium 10% (170.3 g, 227 g)

Generic Equivalent Available: US

Yes: Excludes emulsion-based wash

Pricing: US

Cream (Avar-e Emollient External)

10-5% (per gram): $14.02

Cream (Avar-e Green External)

10-5% (per gram): $13.20

Cream (Avar-e LS External)

10-2% (per gram): $13.41

Cream (Plexion External)

9.8-4.8% (per gram): $13.49

Cream (Sulfacetamide Sodium-Sulfur External)

9.8-4.8% (per gram): $9.31

10-2% (per gram): $7.79 - $11.49

10-5% (per gram): $7.79 - $12.01

Emulsion (Sulfacetamide-Sulfur in Urea External)

10-5% (per mL): $0.70

Kit (Sumadan External)

9-4.5% (per each): $1,072.99

Kit (Sumaxin CP External)

10-4% (per each): $1,100.02

Liquid (Avar Cleanser External)

10-5% (per gram): $3.23

Liquid (Avar LS Cleanser External)

10-2% (per gram): $3.28

Liquid (Plexion Cleanser External)

9.8-4.8% (per gram): $2.92

Liquid (Sulfacetamide Sodium-Sulfur External)

9-4% (per mL): $1.34

9-4.5% (per gram): $0.36 - $0.41

9.8-4.8% (per gram): $0.91 - $2.50

10-2% (per gram): $1.90

10-5% (per gram): $0.62

Liquid (Sumadan Wash External)

9-4.5% (per gram): $2.36

Lotion (Plexion External)

9.8-4.8% (per gram): $14.72

Lotion (Sulfacetamide Sodium-Sulfur External)

9.8-4.8% (per gram): $9.31

10-5% (per gram): $9.39

Pads (Plexion Cleansing Cloth External)

9.8-4.8% (per each): $15.04

Pads (Sulfacetamide Sodium-Sulfur External)

9.8-4.8% (per each): $7.79

Pads (Sumaxin External)

10-4% (per each): $18.33

Suspension (Clenia Plus External)

9-4.25% (per mL): $3.29

Suspension (Sulfacetamide Sodium-Sulfur External)

8-4% (per mL): $1.04

9-4.25% (per mL): $2.96

10-5% (per gram): $9.32

Suspension (SulfaCleanse 8/4 External)

8-4% (per mL): $1.37

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Topical: For external use only. Wash hands prior to use. Avoid contact with eyes, eyelids, lips, and mucous membranes.

Cleanser: Shake well prior to use. Apply to wet skin and massage gently into skin working into full lather for 10 to 20 seconds; rinse skin completely and pat dry skin.

Cleansing cloths/cleansing pads: Moisten skin and cloth/pad with water, work cloth/pad into lather, and massage into skin for 10 to 20 seconds; rinse skin completely and pat dry skin. Dispose in trash; do not flush.

Cream, lotion: Apply to clean, dry skin; massage into skin completely.

Emollient cream: Shake well prior to use (Avar-e). Apply to clean, dry skin; massage into skin completely.

Emollient foam: Wash affected area before use. Shake can vigorously and tap bottom of can onto palm of other hand or a hard surface at least 1 to 2 times, then shake and tap again prior to each use. Foam may remain on skin or may be rinsed off after 1 to 2 minutes.

Suspension: Shake well prior to use. Wet skin and apply to affected area, work into full lather and massage into skin for 10 to 20 seconds, then rinse thoroughly and pat skin dry.

Administration: Pediatric

Topical: For external use only. Avoid contact with eyes, eyelids, lips, and mucous membranes. Wash hands prior to use.

Cleanser: Apply to wet skin and massage gently into skin working into full lather for 10 to 20 seconds; rinse thoroughly and pat dry.

Cleansing cloths/cleansing pads: Moisten skin and cloth/pad with water, work cloth/pad into lather, and massage into skin for 10 to 20 seconds; rinse skin completely and pat dry skin. Dispose in trash; do not flush.

Emollient foam: Apply to clean, dry skin. Consult product-specific labeling for details regarding priming and preparation of product prior to use. Dispense foam onto fingertip and massage into affected areas; foam may remain on skin or may be rinsed off after 1 to 10 minutes.

Use: Labeled Indications

Acne rosacea, acne vulgaris, seborrheic dermatitis: Treatment of acne vulgaris, acne rosacea, and seborrheic dermatitis.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination. Refer to the Sulfacetamide monograph for additional information.

Breastfeeding Considerations

Small amounts of sulfonamides administered orally are excreted in breast milk; it is not known if sulfur and sulfacetamide administered topically is excreted in breast milk. The manufacturer recommends that caution be exercised when administering sulfur and sulfacetamide to breast-feeding women.

Monitoring Parameters

Signs of local irritation and/or sensitization, especially during long-term therapy.

Mechanism of Action

Sulfacetamide interferes with bacterial growth by inhibiting bacterial folic acid synthesis through competitive antagonism of para-aminobenzoic acid (PABA). Sulfur is a keratolytic. Used in combination to inhibit the growth of acne-causing bacteria.

Pharmacokinetics (Adult Data Unless Noted)

Refer to the Sulfacetamide monograph for additional information.

Absorption: Sulfur, topical: ~1%

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (IN) India: Ecnil | Eczim;
  • (PR) Puerto Rico: Avar | Avar Green | Avar ls | Cerisa | Clarifoam | Claris | Clenia | Clenia plus | Garimide | Plexion | Prascion | Prascion ra | Rosac | Rosula | Se 10 5 SS | Sodium sulfacetamide & sulfur | Sodium sulfacetamide & sulfur Wash | Sodium sulfacetamide 10% and sulfur 2% | Sodium sulfacetamide 9.8% and sulfur 4.8% | Sodium sulfacetamide and sulfur | Sodium sulfacetamide sulfur | Sulfatol | Sulfatol c | Sumadan | Sumaxin | Sumaxin ts | Topisulf | Zencia | Zetacet | Zma clear
  1. Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319. [PubMed 11487763]
  2. Avar cleanser (sodium sulfacetamide/sulfur) [prescribing information]. San Antonio, TX: Mission Pharmacal Company; received September 2023.
  3. Avar cleansing pads (sodium sulfacetamide/sulfur) [prescribing information]. San Antonio, TX: Mission Pharmacal Company; July 2013.
  4. Avar-e emollient cream (sodium sulfacetamide/sulfur) [prescribing information]. San Antonio, TX: Mission Pharmacal Company; received September 2023.
  5. Avar-e green cream (sodium sulfacetamide/sulfur) [prescribing information]. San Antonio, TX: Mission Pharmacal Company; received January 2021.
  6. Avar-e LS emollient cream (sodium sulfacetamide/sulfur) [prescribing information]. San Antonio, TX: Mission Pharmacal Company; received January 2021.
  7. Avar LS cleanser (sodium sulfacetamide/sulfur) [prescribing information]. San Antonio, TX: Mission Pharmacal Company; received September 2023.
  8. Avar LS cleansing pad (sodium sulfacetamide/sulfur) [prescribing information]. San Antonio, TX: Mission Pharmacal Company; July 2013.
  9. Brackett CC, Singh H, Block JH. Likelihood and mechanisms of cross-allergenicity between sulfonamide antibiotics and other drugs containing a sulfonamide functional group. Pharmacotherapy. 2004;24(7):856-870. [PubMed 15303450]
  10. Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm. [PubMed 6810084]
  11. Clenia Plus (sodium sulfacetamide and sulfur) [prescribing information]. Canton, MS: Scite Pharma LLC; January 2021.
  12. Johnson KK, Green DL, Rife JP, Limon L. Sulfonamide cross-reactivity: fact or fiction? [published correction appears in Ann Pharmacother. 2005;39(7-8):1373]. Ann Pharmacother. 2005;39(2):290-301. [PubMed 15644481]
  13. "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  14. Plexion cleanser (sodium sulfacetamide/sulfur) [prescribing information]. Wilmington, DE: Eckson Labs; July 2021.
  15. Plexion cleansing cloths (sodium sulfacetamide/sulfur) [prescribing information]. Houston, TX: Artesa Labs, LLC; July 2018.
  16. Plexion cream (sodium sulfacetamide/sulfur) [prescribing information]. Houston, TX: Brava Pharmaceuticals LLC; July 2018.
  17. Plexion lotion (sodium sulfacetamide/sulfur) [prescribing information]. Houston, TX: Brava Pharmaceuticals LLC; July 2018.
  18. Slatore CG, Tilles SA. Sulfonamide hypersensitivity. Immunol Allergy Clin North Am. 2004;24(3):477-490. [PubMed 15242722]
  19. Sodium sulfacetamide 8%/sulfur 4% suspension [prescribing information]. Nashville, TN: Westminster Pharmaceuticals LLC; April 2021.
  20. Sodium sulfacetamide 10%/sulfur 2% cleanser [prescribing information]. Red Bank, NJ: Bi-Coastal Pharma Internationl LLC; December 2014.
  21. SSS 10%-5% emollient foam 60 g (sodium sulfacetamide/sulfur) [prescribing information]. Alpharetta, GA: Acella Pharmaceuticals LLC; March 2013.
  22. Sulfamez Wash (sulfur and sulfacetamide) [prescribing information]. Las Vegas, NV: Mesora Pharma; received March 2018.
  23. Sumadan kit (sodium sulfacetamide/sulfur) [prescribing information]. Fairfield, NJ: Medimetriks Pharmaceuticals Inc; received December 2011.
  24. Sumadan wash (sodium sulfacetamide/sulfur) [prescribing information]. Fairfield, NJ: Medimetriks Pharmaceuticals Inc; August 2020.
  25. Sumadan XLT (sodium sulfacetamide/sulfur) [prescribing information]. Fairfield, NJ: Medimetriks Pharmaceuticals Inc; received November 2013.
  26. Sumaxin wash and topical suspension (sodium sulfacetamide/sulfur) [prescribing information]. Fairfield, NJ: Medimetriks Pharmaceuticals Inc; October 2017.
  27. Sumaxin CP Kit (sodium sulfacetamide/sulfur) [prescribing information]. Fairfield, NJ: Medimetriks Pharmaceuticals Inc; December 2011.
  28. Tornero P, De Barrio M, Baeza ML, Herrero T. Cross-reactivity among p-amino group compounds in sulfonamide fixed drug eruption: diagnostic value of patch testing. Contact Dermatitis. 2004;51(2):57-62. [PubMed 15373844]
  29. Zawodniak A, Lochmatter P, Beeler A, Pichler WJ. Cross-reactivity in drug hypersensitivity reactions to sulfasalazine and sulfamethoxazole. Int Arch Allergy Immunol. 2010;153(2):152-156. [PubMed 20413982]
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