Benzoic Acid + Salicylic Acid

Allopathic
Indications
  • Approved Indications:
    • Treatment of mild to moderate acne vulgaris characterized by comedones, papules, and pustules.
    • Management of hyperkeratotic skin disorders such as psoriasis and seborrheic dermatitis.
    • Keratolytic treatment of scaly and thickened skin lesions, including warts, corns, and calluses.
    • Adjunctive therapy for dandruff and seborrhea of the scalp.
    • Used to soften and remove excessive keratin buildup.
  • Off-label Uses:
    • Control of localized hyperkeratosis in eczema or lichen planus under medical supervision.
    • Preparation of skin for other topical treatments by reducing scaling.
Dosage & Administration
  • Route: Topical application.
  • Adults and Adolescents: Apply a thin layer of the preparation once or twice daily to the affected areas. The frequency and duration depend on the severity and response, generally continued for several weeks.
  • Pediatrics: Use cautiously; limit application to small areas under medical guidance due to risk of systemic absorption.
  • Special Populations: Avoid application on broken, inflamed, or extensively damaged skin to reduce irritation and systemic absorption.
  • Administration Tips: Cleanse and dry the area before applying. Avoid contact with eyes, mucous membranes, and do not apply under occlusive dressings unless directed. Wash hands after application.
Mechanism of Action (MOA)

Benzoic acid exhibits mild antiseptic and antifungal properties and contributes keratolytic effects by lowering skin pH, creating an inhospitable environment for microbial growth. Salicylic acid, a beta-hydroxy acid, works primarily as a keratolytic agent by solubilizing intercellular cement in the stratum corneum, thereby promoting exfoliation of dead skin cells and preventing follicular plugging. Together, they soften and remove scales and hyperkeratotic skin, reduce microbial colonization, and improve lesion appearance.

Pharmacokinetics
  • Absorption: Minimal systemic absorption through intact skin; absorption may increase with application over large areas, broken skin, or under occlusion.
  • Distribution: After absorption, benzoic acid is metabolized in the liver; salicylic acid distributes systemically when absorbed.
  • Metabolism: Benzoic acid is conjugated with glycine to form hippuric acid, excreted in urine. Salicylic acid undergoes hepatic conjugation.
  • Excretion: Primarily renal elimination of metabolites.
Pregnancy Category & Lactation
  • Pregnancy: No controlled human studies; topical use at recommended doses is considered low risk. Use only if clearly necessary.
  • Lactation: Limited data; minimal systemic absorption suggests low risk during breastfeeding, but caution is advised.
Therapeutic Class
  • Therapeutic Class: Dermatologic agent
  • Subclass: Keratolytic and antiseptic combination
Contraindications
  • Hypersensitivity to benzoic acid, salicylic acid, or any formulation excipients.
  • Application on open wounds, ulcers, or severely inflamed skin.
  • Known allergy to salicylates (aspirin sensitivity).
Warnings & Precautions
  • Avoid contact with eyes, mucous membranes, and damaged skin.
  • Use cautiously in patients with sensitive skin to minimize irritation.
  • Prolonged or excessive use may increase risk of systemic toxicity, especially in children.
  • Discontinue if severe irritation or allergic reactions occur.
  • Avoid use in children under 2 years without medical supervision.
Side Effects
  • Common: Local skin irritation, redness, dryness, peeling, burning, or itching at the application site.
  • Rare but Serious: Allergic contact dermatitis, salicylate toxicity (e.g., tinnitus, dizziness) with excessive use, photosensitivity.
Drug Interactions
  • Minimal systemic absorption limits interaction potential.
  • Avoid concurrent use with other topical irritants or salicylate-containing products to prevent additive irritation or toxicity.
Recent Updates or Guidelines
  • Combination keratolytic agents like benzoic acid plus salicylic acid continue to be recommended in dermatology guidelines for managing acne and hyperkeratotic disorders.
  • Recent guidance emphasizes caution in pediatric use and avoiding excessive application to reduce adverse effects.
Storage Conditions
  • Store at 20°C to 25°C (68°F to 77°F).
  • Protect from moisture, heat, and direct light.
  • Keep container tightly closed when not in use.
  • Avoid freezing.
  • Keep out of reach of children.