Precipitated Sulpher + Salicylic Acid

Approved and Clinically Accepted Uses:

• Acne Vulgaris (Mild to Moderate):
  Used to treat comedonal and inflammatory acne lesions due to its keratolytic, anti-inflammatory, and antibacterial properties.
• Seborrheic Dermatitis & Dandruff:
  Helps reduce flaking, scaling, and inflammation of the scalp and skin.
• Psoriasis (Mild Forms):
  Facilitates desquamation and helps control thickened, scaly plaques.
• Hyperkeratotic Skin Conditions:
  Such as corns, calluses, and keratosis pilaris.
• Tinea Versicolor (Adjuvant Use):
  Aids in exfoliation and removal of surface fungal elements.
• Scabies (Adjunct Therapy):
  Particularly in infants and pregnant women when systemic scabicides are contraindicated.
• Rosacea (Off-label):
  Occasionally used for pustular and erythematous facial lesions.

Adults:

• Topical Use (Creams, Gels, Lotions, Ointments, Soaps):
  Apply a thin layer to the affected area once or twice daily, depending on product concentration and tolerance.
• Scalp Application:
  Apply as directed, leave for 5–10 minutes, then rinse thoroughly.

Pediatrics (≥2 Years):

• Use cautiously with lower concentrations (e.g., 0.5–2% salicylic acid) under supervision for acne, dandruff, or scabies.

Elderly:

• Use standard adult dosing with careful observation for irritation due to thinner skin.

Renal/Hepatic Impairment:

• Avoid application to large surface areas to minimize systemic absorption, especially in renal impairment (due to risk of salicylate accumulation).

Administration Notes:

• For external use only.
• Avoid contact with eyes, mouth, mucous membranes, and broken skin.
• Wash hands thoroughly after application.

Precipitated Sulphur acts as a keratolytic, antifungal, antibacterial, and scabicidal agent. It promotes skin exfoliation, reduces microbial growth, and may modulate sebaceous activity. Salicylic Acid, a beta-hydroxy acid (BHA), penetrates sebaceous follicles and dissolves intercellular cement, promoting desquamation and unclogging pores. Together, the combination enhances exfoliation, reduces oiliness and inflammation, and suppresses acne-causing bacteria and fungi on the skin surface.

Topical Salicylic Acid:

• Absorption:
  Low systemic absorption with localized application; increased with damaged skin, occlusion, or high concentrations.
• Metabolism:
  Absorbed salicylic acid is metabolized hepatically to salicyluric acid and other metabolites.
• Elimination:
  Excreted primarily via the kidneys.
• Half-Life (Systemically Absorbed):
  ~2–3 hours (varies with dose and renal function).

Topical Sulphur:

• Absorption:
  Minimal to no systemic absorption.
• Metabolism & Excretion:
  Not significantly systemically metabolized or excreted.

• Pregnancy:
• Salicylic Acid: Classified as Pregnancy Category C. Avoid high concentrations and prolonged use during pregnancy, especially in the first trimester.
• Sulphur: Considered safe in limited topical use.
• Lactation:
• Likely safe with limited use on small areas.
• Avoid applying to areas that may come in contact with the nursing infant (e.g., breasts).

• Primary Class: Topical Keratolytic and Anti-Acne Agent
• Subclass:
• Sulphur: Antiseptic, Scabicidal, Keratolytic
• Salicylic Acid: Beta-Hydroxy Acid (BHA), Keratolytic, Comedolytic

• Hypersensitivity to sulphur, salicylic acid, or any formulation component
• Inflamed, broken, or infected skin
• Application to large surface areas in children or patients with renal impairment
• Children under 2 months of age

• Salicylate Toxicity:
  Risk increases with extensive use, occlusion, damaged skin, or renal impairment.
• Skin Irritation:
  May cause dryness, peeling, erythema, or burning—especially at higher concentrations.
• Avoid Eyes and Mucosa:
  Rinse immediately if contact occurs.
• Photosensitivity:
  Increases sensitivity to sunlight; recommend using sunscreen during treatment.
• Use in Children:
  Avoid application over large areas due to enhanced absorption and risk of toxicity.

Common:

• Mild burning or stinging
• Dryness or peeling
• Redness (erythema)
• Itching
• Skin discoloration (temporary)

Less Common:

• Contact dermatitis
• Folliculitis
• Secondary bacterial infection (with overuse)

Rare but Serious:

• Systemic salicylate toxicity (tinnitus, dizziness, nausea) if applied over large areas or under occlusion
• Severe allergic reactions (rare)

• Topical Retinoids (e.g., tretinoin):
  May enhance irritation—use at different times of day if needed.
• Other Keratolytics (e.g., benzoyl peroxide):
  May increase drying and irritation.
• Systemic Salicylates (aspirin, etc.):
  Additive salicylate load—caution in patients taking oral salicylates.
• No known CYP450 interactions (minimal systemic metabolism from topical use).

• Widely included in first-line topical therapies for mild acne, often combined with other agents (e.g., benzoyl peroxide, retinoids).
• Lower concentrations (0.5–2% salicylic acid) now preferred in modern formulations to reduce irritation.
• Newer formulations (e.g., foam, mask, gel-based) improve tolerability and cosmetic acceptance.
• Emphasized in current dermatologic guidelines as cost-effective adjunct in treating oily skin and keratotic disorders.

• Temperature: Store at 20°C to 25°C (68°F to 77°F)
• Humidity: Keep in tightly sealed containers; avoid moisture.
• Light Protection: Store away from direct sunlight.
• Handling:
• For external use only
• Do not freeze
• Shake well before use (for suspensions or lotions)