International reference: 1 US FDA recall for this ingredient

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient. (salicyclic)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Ghana.

Valid Ghana · FDA Ghana

SALICYLIC ACID OINTMENT

Salicyclic Acid

FDA/GD.05-10632 Salicyclic Acid 2.0%w/w

What it does

Salicylic acid is a medication primarily used to treat skin conditions.

Commonly used for: acne, warts, dandruff, psoriasis

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/GD.05-10632
Registration date
2024-04-05
Expiry date
2028-12-31
Status
Valid
Active ingredient
Salicyclic Acid
Dosage form
Salicyclic Acid
Strength
2.0%w/w
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Dannex Ayrton Starwin
Country of origin
Ghana
Manufacturer location
Dannex Ayrton, Starwin PLC, Dadeban Rd, Accra, Ghana

Source: Food and Drugs Authority · fetched 2026-04-18 08:37:32 · updated 2026-10-20 04:00:12

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Salicylic acid is a medication primarily used to treat skin conditions.

What it treats

  • acne
  • warts
  • dandruff
  • psoriasis

How it works

It helps to remove dead skin cells and reduce inflammation, making it effective for various skin conditions.

Who it's for

It is suitable for individuals dealing with certain skin issues like acne or warts.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: salicyclic

Salicylic acid is a beta hydroxy acid (BHA) commonly used in dermatology for its keratolytic, anti-inflammatory, and exfoliating properties. It is primarily indicated for the treatment of acne, psoriasis, warts, and other skin conditions. Salicylic acid works by promoting the shedding of dead skin cells and reducing inflammation in the affected areas.

Indications

  • Acne vulgaris
  • Psoriasis
  • Warts
  • Seborrheic dermatitis
  • Dandruff
  • Hyperkeratotic conditions

Dosage

Children: Refer to appropriate paediatric guidelines as per product formulation.

Adults: Topical application varies by formulation; follow specific product guidelines.

Mechanism of action

Salicylic acid exerts its effects by penetrating the skin and dissolving the bonds that hold skin cells together, which facilitates the removal of the outer layer of skin. It also has anti-inflammatory properties that help reduce the redness and swelling associated with acne and other skin disorders. Salicylic acid is known to inhibit the enzyme cyclooxygenase (COX), leading to decreased production of inflammatory mediators.

Pharmacodynamics

Salicylic acid demonstrates keratolytic effects by softening and loosening the outer layer of skin. Its ability to penetrate hair follicles allows it to address acne at its source by clearing plugged pores. The anti-inflammatory action reduces the inflammatory response in acne lesions, leading to a decrease in swelling and redness. The concentration of salicylic acid used affects its effectiveness; higher concentrations are typically utilized for more severe conditions.

Pharmacokinetics

Salicylic acid is absorbed through the skin, with systemic absorption being minimal when used topically. The onset of action can vary depending on the formulation and concentration used. The metabolic pathways primarily involve conjugation with glycine or glucuronic acid in the liver, leading to excretion via the kidneys. Its half-life can vary, but topical formulations are designed for localized effects, minimizing systemic exposure.

Contra-indications

  • Hypersensitivity to salicylic acid or any of its components
  • Active peptic ulcer disease
  • Severe liver or kidney impairment
  • Children and adolescents with viral infections (risk of Reye's syndrome)

Adverse effects

  • Gastrointestinal disturbance (nausea, vomiting, dyspepsia)
  • Tinnitus or hearing loss (especially at high doses)
  • Allergic reactions (including rash or urticaria)
  • Skin irritation or burning sensation (when used topically)
  • Respiratory alkalosis (in cases of overdose)

Interactions

  • Increased risk of bleeding when used with anticoagulants such as warfarin
  • Potential interaction with methotrexate, leading to increased toxicity
  • May decrease the efficacy of certain antihypertensive medications
  • Use with caution in conjunction with other non-steroidal anti-inflammatory drugs (NSAIDs)

Precautions

  • Caution in patients with asthma or a history of asthma
  • Use with caution in patients with a history of gastrointestinal disorders
  • Regular monitoring of renal function may be necessary in long-term use
  • Avoid in patients with known salicylate intolerance

Pregnancy

Salicylic acid is generally avoided during pregnancy, especially in the third trimester, due to potential risks of fetal harm.

Breast-feeding

Salicylic acid is excreted in breast milk; caution is advised when using topically or systemically.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

Formulations

  • Topical ointment or gel
  • Liquid solution for topical use
  • Tablets and capsules for systemic use

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.