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Sulfur and salicylic acid: Drug information

Sulfur and salicylic acid: Drug information
(For additional information see "Sulfur and salicylic acid: Pediatric drug information" and see "Sulfur and salicylic acid: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Pernox [OTC];
  • Sebex [OTC];
  • Sebulex [OTC] [DSC]
Pharmacologic Category
  • Antiseborrheic Agent, Topical
Dosing: Adult
Dermatologic conditions

Dermatologic conditions: Topical: Shampoo: Initial: Wet the scalp or skin and massage enough shampoo to form a lather, massage area for 3 to 5 minutes, rinse thoroughly then repeat application. Use at least twice weekly recommended.

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Sulfur and salicylic acid: Pediatric drug information")

Dandruff, scalp seborrhea

Dandruff, scalp seborrhea: Limited data available: Adolescents: Topical: Shampoo: Initial: Wet the scalp or skin and massage enough shampoo to form a lather, massage area for 3 to 5 minutes, rinse thoroughly then repeat application. Use at least twice weekly (Ref).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Local: Topical preparations containing 2% to 5% sulfur generally are well tolerated, local irritation may occur, concentration >15% is very irritating to the skin, higher concentration (eg, 10% or higher) may cause systemic toxicity (eg, headache, vomiting, muscle cramps, dizziness, collapse)

Contraindications

Use on large area of the body (seborrheic dermatitis or psoriasis)

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Rare but serious and potentially life-threatening allergic reactions or severe irritation have been reported with use of topical OTC benzoyl peroxide or salicylic acid containing products; it has not been determined if the reactions are due to the active ingredients (benzoyl peroxide or salicylic acid), the inactive ingredients, or a combination of both. Hypersensitivity reactions may occur within minutes to a day or longer after product use and differ from local skin irritation (redness, burning, dryness, itching, peeling or slight swelling) that may occur at the site of product application. Treatment should be discontinued if hives or itching develop; patients should seek emergency medical attention if reactions such as throat tightness, difficulty breathing, feeling faint, or swelling of the eyes, face, lips, or tongue develop. Before using a topical OTC acne product for the first time, consumers should apply a small amount to 1 or 2 small affected areas for 3 days to make sure hypersensitivity symptoms do not develop (FDA Drug Safety Communication, 2014).

Special populations:

• Pediatric: Infants are more sensitive to sulfur than adults; do not use in children <2 years.

Other warnings/precautions:

• Appropriate use: For external use only; avoid contact with eyes; discontinue use if skin irritation develops.

Dosage Forms: US

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

Cleanser, topical [scrub]:

Pernox: Sulfur 2% and salicylic acid 1.5% (113 g, 141 g)

Shampoo, topical:

Sebex: Sulfur 2% and salicylic acid 2% (118 mL)

Sebulex®: Sulfur 2% and salicylic acid 2% (200 g [DSC])

Generic Equivalent Available: US

Yes

Pricing: US

Bar (SAStid Soap External)

3-5% (per each): $4.32

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

For external use only; avoid contact with eyes. Shake well prior to use.

Administration: Pediatric

Topical: Avoid contact with the eyes; for external use only. Shake well prior to use.

Use: Labeled Indications

Dermatological conditions: Symptom control of dandruff, seborrheic dermatitis, and psoriasis

Medication Safety Issues
Pediatric patients: High-risk medication:

KIDs List: Salicylates, when used in pediatric patients <18 years of age with suspicion of viral illness (influenza, chickenpox), are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list and should be used with caution due to risk of Reye syndrome (weak recommendation; very low quality of evidence) (PPA [Meyers 2020]).

Pregnancy Considerations

Refer to salicylic acid monograph.

Breastfeeding Considerations

Refer to salicylic acid monograph.

Mechanism of Action

Salicylic acid works synergistically with sulfur in its keratolytic action to break down keratin and promote skin peeling

Pharmacokinetics (Adult Data Unless Noted)

Absorption: 1% of topically applied sulfur is absorbed

Metabolism: Sulfur is reduced to hydrogen sulfide

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

  • (AE) United Arab Emirates: Sebulex;
  • (AR) Argentina: Sastid;
  • (BR) Brazil: Sastid;
  • (CL) Chile: Sastid;
  • (DO) Dominican Republic: Sastid;
  • (GB) United Kingdom: Meted;
  • (IE) Ireland: Clearasil | Meted;
  • (JO) Jordan: Fostex medicated | Sebulex;
  • (LB) Lebanon: Sebulex;
  • (PR) Puerto Rico: Meted | Pernox | Sebulex;
  • (PY) Paraguay: Sastid;
  • (SA) Saudi Arabia: Sebulex;
  • (SE) Sweden: Sevorex;
  • (UY) Uruguay: Sastid;
  • (ZA) South Africa: Sastid
  1. FDA Drug Safety Communication. http://www.fda.gov/downloads/Drugs/DrugSafety/UCM402663.pdf.
  2. Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191. [PubMed 32265601]
  3. Poindexter GB, Burkhart CN, Morrell DS. Therapies for pediatric seborrheic dermatitis. Pediatr Ann. 2009;38(6):333-338. [PubMed 19588677]
  4. Sebex shampoo (salicylic acid, colloidal sulfur) [prescribing information]. Duluth, GA: Rugby Laboratories Inc; January 2017.
Topic 83320 Version 80.0

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