Malic Acid + Benzoic acid + Salicylic acid

Approved Indications:

• Acne Vulgaris: Treatment of comedones, papules, pustules, and mild inflammatory acne.
• Hyperkeratotic Skin Conditions: Management of calluses, corns, and keratosis pilaris by softening thickened skin.
• Seborrheic Dermatitis: Reduces scaling and promotes exfoliation.
• Psoriasis (Mild to Moderate): Adjunctive therapy to help reduce scaling and enhance penetration of other topical agents.

Clinically Accepted Off-Label Uses:

• Warts (Verruca Vulgaris): As a keratolytic agent to soften hyperkeratotic skin for enhanced penetration of antiviral or caustic agents.
• Fungal Skin Infections (e.g., tinea): Supportive use to promote desquamation and aid antifungal absorption.

Route of Administration: Topical

Adults and Adolescents (≥12 years):

• Apply a thin layer to the affected area once or twice daily.
• Begin with once-daily use to assess tolerance; increase to twice daily if well tolerated.
• Wash the affected area and pat dry before application.

Pediatrics (<12 years):

• Safety and efficacy have not been established for this fixed combination in children under 12 years.

Geriatrics:

• No specific dose adjustment; monitor for increased skin sensitivity or irritation.

Special Populations:

• Renal Impairment: Avoid application to large surface areas due to potential salicylate absorption.
• Hepatic Impairment: No specific adjustment needed.

Administration Notes:

• Avoid contact with eyes, mucous membranes, or broken skin.
• Do not apply under occlusion unless directed by a physician.
• Wash hands thoroughly after application unless the hands are the treatment site.

This combination exerts its therapeutic effects through keratolytic, exfoliative, and mild antimicrobial actions:

• Salicylic Acid is a beta-hydroxy acid that softens and breaks down keratin in the stratum corneum, facilitating exfoliation and unclogging pores.
• Benzoic Acid has mild antibacterial and antifungal properties and enhances the effectiveness of other active agents by increasing skin permeability.
• Malic Acid, an alpha-hydroxy acid (AHA), promotes epidermal exfoliation by reducing corneocyte cohesion, improving skin texture and renewal.

Together, these agents help remove dead skin cells, decrease follicular plugging, and improve the penetration of other topical medications.

• Absorption: Minimal systemic absorption at therapeutic topical doses; salicylic acid may be absorbed if applied to large areas or damaged skin.
• Distribution: Not systemically relevant under standard topical use.
• Metabolism:
• Salicylic acid: Hepatically metabolized to salicyluric acid
• Benzoic acid: Converted to hippuric acid
• Malic acid: Participates in endogenous metabolism (Krebs cycle)
• Elimination:
• Salicylates and benzoates are excreted via the kidneys.
• Onset of Action: Clinical improvement usually observed within 1–2 weeks; full effect in 4–6 weeks.

• Pregnancy:
• Topical salicylic acid is classified as Pregnancy Category C (FDA, discontinued system). Use in limited areas is generally considered safe. Avoid extensive or occlusive use.
• Benzoic and malic acids have limited human data; short-term topical use is likely safe.
• Use during pregnancy only if clearly needed.
• Lactation:
• Salicylic acid is minimally absorbed and unlikely to pose a risk when not applied to the chest.
• Advise mothers to avoid applying near or on the nipple area to prevent infant exposure.

• Primary Class: Keratolytic and Exfoliative Dermatologic Agent
• Subclasses:
• Salicylic Acid: Beta-Hydroxy Acid (BHA)
• Malic Acid: Alpha-Hydroxy Acid (AHA)
• Benzoic Acid: Topical Antiseptic/Preservative

• Known hypersensitivity to salicylic acid, benzoic acid, malic acid, or any excipients
• Inflamed, broken, or irritated skin
• Use in children under 12 years of age
• Application to large areas in patients with renal impairment

• Skin Irritation: Burning, redness, or peeling may occur, especially with overuse.
• Photosensitivity: Increased sensitivity to sunlight; recommend daily use of sunscreen.
• Systemic Absorption Risk: Avoid applying to large body areas or broken skin to prevent salicylate toxicity.
• Pre-existing Skin Conditions: Use with caution in patients with eczema, rosacea, or very sensitive skin.
• Avoid Occlusive Dressings: Do not use with bandages unless advised by a healthcare provider.

Common (Usually Mild):

• Skin: Dryness, scaling, redness, peeling, mild burning or stinging

Less Common:

• Contact Dermatitis: Local allergic or irritant reaction
• Photosensitivity: Enhanced skin response to sunlight
• Hypopigmentation or Hyperpigmentation: In some skin types

Rare but Serious:

• Salicylism: Headache, tinnitus, dizziness (from excessive use or absorption)
• Severe Irritation or Erosion: Especially if applied to damaged or occluded skin

• Topical Retinoids (e.g., tretinoin): Increased risk of irritation; stagger application times if used concurrently.
• Other Keratolytic Agents (e.g., sulfur, urea): Potential additive irritation.
• Systemic NSAIDs or Aspirin: Theoretical additive salicylate load with overuse of topical salicylic acid (rare).

Enzyme Involvement:

• No known interaction with CYP450 enzymes due to minimal systemic absorption.

• Dermatology guidelines continue to support the use of AHAs and BHAs in combination therapy for acne and keratotic skin conditions.
• Emphasis on using low concentrations and limited surface area to reduce systemic absorption risks.
• Updated product labeling may include cautionary language for use during pregnancy or lactation.

• Temperature: Store at 20°C to 25°C (68°F to 77°F)
• Humidity: Protect from moisture; store in a dry place
• Light: Store away from direct sunlight
• Handling Instructions:
• Keep container tightly closed when not in use
• Shake well before use if in liquid form
• Do not freeze