Version May 2024
Acne vulgaris: Topical: Klaron lotion, topical suspension: Apply thin film to affected area twice daily.
Bacterial infections: Topical:
Cream, Ovace Plus lotion: Apply to affected areas twice daily for 8 to 10 days.
Foam: Apply to affected areas 1 to 3 times daily.
Wash: Apply to affected areas 1 to 2 times daily for 8 to 10 days.
Scaling dermatoses: Topical:
Cream, Ovace Plus lotion: Apply to affected areas twice daily for 8 to 10 days. Dosing interval may be lengthened as eruption subsides. Applications once or twice weekly, or every other week may be used for prevention. If treatment needs to be reinitiated, start therapy as a twice-daily regimen.
Foam: Apply to affected areas 1 to 3 times daily.
Shampoo: Wash hair at least twice weekly.
Wash:
Ovace Plus Wash Liquid, Ovace Plus Wash cleansing gel, Ovace wash: Wash affected areas twice with a 10- to 20-second interval between washings; repeat twice daily for 8 to 10 days. Dosing interval may be lengthened as eruption subsides. Applications once or twice weekly, or every other week may be used for prevention. If treatment needs to be reinitiated, start therapy as a twice-daily regimen.
SEB-Prev: Wash affected areas twice daily for 8 to 10 days. Dosing interval may be lengthened as eruption subsides. Applications once or twice weekly, or every other week may be used for prevention. If treatment needs to be reinitiated, start therapy as a twice-daily regimen.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Refer to adult dosing.
(For additional information see "Sulfacetamide (topical): Pediatric drug information")
Acne vulgaris: Children ≥12 years and Adolescents: Topical: Lotion 10%: Apply thin film to affected area twice daily
Seborrheic dermatitis, including seborrhea sicca: Children ≥12 years and Adolescents: Topical:
Cream, Lotion 9.8%: Apply to affected areas twice daily for 8 to 10 days. Dosing interval may be lengthened as eruption subsides. Applications once or twice weekly, or every other week may be used for prevention. If treatment needs to be reinitiated, start therapy as a twice daily regimen.
Foam: Apply to affected areas 1 to 3 times daily
Gel, Wash: Wash affected area twice with a 10- to 20-second interval between washings; repeat application twice daily for 8 to 10 days. Dosing interval may be lengthened as eruption subsides. Applications once or twice weekly, or every other week may be used for prevention. If treatment needs to be reinitiated, start therapy as a twice daily regimen.
Shampoo: Wash hair at least twice weekly
Bacterial infections (secondary), cutaneous: Children ≥12 years and Adolescents: Topical:
Cream, Lotion 9.8%: Apply to affected areas twice daily for 8 to 10 days
Foam: Apply to affected areas 1 to 3 times daily
Gel: Wash affected area once daily for 8 to 10 days
Wash: Wash affected area once or twice daily for 8 to 10 days
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined; adverse events may vary based on formulation.
Dermatologic: Burning sensation of skin, erythema, pruritus, Stevens-Johnson syndrome, stinging of the skin, toxic epidermal necrolysis
Hematologic & oncologic: Agranulocytosis, aplastic anemia, hematologic abnormality
Hepatic: Fulminant hepatic necrosis
Hypersensitivity: Hypersensitivity reaction
Local: Local irritation, localized edema
Neuromuscular & skeletal: Systemic lupus erythematosus
Known or suspected hypersensitivity to sulfonamides or any component of the formulation; kidney disease (Ovace Plus Wash [cleansing gel/liquid], Ovace Plus lotion, Ovace Plus foam, Plexion NS shampoo).
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.
Concerns related to adverse effects:
• Autoimmune effects: 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, systemic lupus erythematosus, 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 suggests 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; not for ophthalmic use; avoid contact with eyes and mucous membranes. Discontinue use if irritation, rash, or signs of hypersensitivity occur. Monitor closely for local irritation and/or sensitization during long-term therapy.
• Infection: Application to infected area containing nonsusceptible organisms may cause proliferation of the organism.
• Metabisulfites: Some products contain sodium metabisulfite which may cause allergic reactions in certain individuals (eg, asthmatic patients).
• Other topical products: Not compatible with silver-containing products.
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
APOP gel is formulated in a vehicle containing 0.5% bakuchiol, a natural compound extracted from Psoralea corylifolia purported to exert antimicrobial and anti-inflammatory activity, as well as reduce scarring from acne lesions.
Some generic 10% lotion products are referred to as “topical suspensions” in the manufacturer’s labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External, as sodium:
Ovace Plus: 10% (57 g) [contains benzyl alcohol, butylparaben, cetyl alcohol, disodium edta, ethylparaben, methylparaben, propylparaben]
Foam, External:
Ovace Plus: 9.8% (100 g [DSC]) [contains benzyl alcohol, cetyl alcohol, propylene glycol]
Gel, External, as sodium:
Ovace Plus Wash: 10% (355 mL) [contains benzyl alcohol, cetearyl alcohol, propylene glycol]
Generic: 10% (355 mL)
Liquid, External:
Sodium Sulfacetamide-Bakuchiol: 10% (355 mL) [contains disodium edta, methylparaben]
Liquid, External, as sodium:
Ovace Plus Wash: 10% (473 mL) [contains cetearyl alcohol, edetate (edta) disodium, methylparaben]
Ovace Wash: 10% (180 mL, 355 mL [DSC]) [contains edetate (edta) disodium, methylparaben]
Generic: 10% (177 g, 355 g, 454 g, 480 g, 177 mL, 240 mL, 354.8 mL, 355 mL, 360 mL, 480 mL)
Lotion, External, as sodium:
Klaron: 10% (118 mL) [contains disodium edta, methylparaben, propylene glycol, sodium metabisulfite]
Ovace Plus: 9.8% (57 g) [contains benzyl alcohol, cetyl alcohol, disodium edta]
Generic: 10% (118 mL)
Shampoo, External, as sodium:
Ovace Plus: 10% (237 mL) [contains cetearyl alcohol, methylparaben, propylparaben]
Plexion NS: 9.8% (237 mL) [contains edetate (edta) disodium, methylparaben, propylene glycol, propylparaben]
Generic: 9.8% (237 mL); 10% (237 mL)
May be product dependent
Cream (Ovace Plus External)
10% (per gram): $11.08
Gel (Ovace Plus Wash External)
10% (per mL): $2.27
Gel (Sulfacetamide Sodium (Cleans) External)
10% (per mL): $1.41
Liquid (Ovace Plus Wash External)
10% (per mL): $1.35
Liquid (Ovace Wash External)
10% (per mL): $2.40
Liquid (Sulfacetamide Sodium External)
10% (per mL): $0.47
Lotion (Klaron External)
10% (per mL): $2.99
Lotion (Ovace Plus External)
9.8% (per gram): $11.60
Lotion (Sulfacetamide Sodium (Acne) External)
10% (per mL): $1.60
Shampoo (Ovace Plus External)
10% (per mL): $3.02
Shampoo (Plexion NS External)
9.8% (per mL): $2.15
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.
Topical: Avoid contact with eyes and mucous membranes.
Cream, lotion, topical suspension: Shake well prior to use.
Foam: Cleanse affected skin thoroughly and pat dry before each application. Shake well prior to use. Dispense into palm of hand. Massage into affected areas and wait 10 minutes; rinse thoroughly with water and pat dry. Alternatively, foam may remain on skin after removing any excess product.
Shampoo: Shake well prior to use. Apply to wet hair and massage vigorously into scalp; thoroughly rinse hair.
Wash: Apply to wet skin and massage into a full lather, rinse thoroughly with plain water, and pat dry. If skin dryness occurs, rinse off early or use less frequently. When used for scaling dermatitis, regular shampooing after use is not necessary; however, hair should be shampooed at least once weekly.
For external topical use only; avoid contact with eyes and mucous membranes.
Foam: Cleanse affected skin thoroughly and pat dry before each application. Shake well prior to use. Dispense into palm of hand. Massage into affected areas and wait 10 minutes; rinse thoroughly with water and pat dry. Alternatively, foam may remain on skin after removing any excess product.
Lotion: Shake lotion well prior to use; apply a thin film to affected area.
Shampoo: Shake shampoo well prior to use. Apply to wet hair and massage vigorously into scalp; thoroughly rinse hair.
Gel, Wash: Apply to wet hair or skin and massage into a full lather; rinse thoroughly and pat dry; repeat after 10 to 20 seconds (for seborrheic dermatitis). If skin dryness occurs, rinse off early or use less frequently. Regular shampooing after use on hair is not necessary; however, hair should be shampooed at least once weekly.
Acne (Klaron lotion, topical suspension): Treatment of acne vulgaris.
Bacterial infections (cream, wash, Ovace Plus lotion and foam): Treatment of bacterial infections of the skin.
Scaling dermatoses (cream, shampoo, wash, Ovace Plus lotion and foam): Treatment of scaling dermatoses (seborrheic dermatitis and seborrhea sicca [dandruff]).
Klaron may be confused with Klor-Con
None known.
There are no known significant interactions.
Animal reproduction studies have not been conducted. The amount of sulfacetamide available systemically following topical administration is unknown. Use of systemic sulfonamides during pregnancy may cause kernicterus in the newborn.
Small amounts of sulfonamides administered orally are excreted in breast milk; it is not known if sulfacetamide administered topically is excreted in breast milk. Use of systemic sulfonamides while breast-feeding may cause kernicterus in the newborn.
Response to therapy, signs of local irritation and/or sensitization, especially during long-term therapy.
Interferes with bacterial growth by inhibiting bacterial folic acid synthesis through competitive antagonism of PABA
Absorption: Significant absorption through skin has been reported; percutaneous absorption about 4%.
Metabolism: Sulfanilamide (major metabolite)
Half-life elimination: 7 to 13 hours
Excretion: Urine 0.08% to 0.33%
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