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KERASAL 10% OINTMENT 50ML
- Sku : I-014803
Key features
KERASAL 10% Ointment is a topical ointment containing salicylic acid 10% as the active ingredient. Salicylic acid acts as a keratolytic, breaking down intercellular cement in the stratum corneum to reduce corneocyte cohesion and promote desquamation and softening of thickened skin. It is used to soften and aid the removal of hyperkeratotic lesions such as calluses, corns and warts. Available OTC in a 50 ml tube.- Brand: KERASAL
- Active Ingredient: SALICYLIC ACID 10%
- Strength: 10%
- Dosage Form: Ointment
- Pack Size: 50 ml
- Route: Topical
- Prescription Status: OTC
- Therapeutic Class: Dermatological
- Pharmacological Group: Antifungals (Topical)
- Drug Class: Keratolytic Agent / Topical Salicylate
- Manufacturer: Dallah Pharma Factory
- Country of Origin: Saudi Arabia
- SFDA Registration No.: 2108245792
- Shelf Life: 36 months
- Storage: store below 25°c
- Skin Condition: Psoriasis, Acne, Fungal, General Hyperkeratosis
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Dosage & Administration
Maximum Dose
No universally standardized maximum dose; limit to small localized areas and avoid large body-surface application or occlusion (especially in children).
Children's Dosage
Not recommended in children under 2 years. In children 2-12 years: use with caution, limit application area, avoid occlusion; lower concentrations (2-5%) preferred. Children over 12 years: standard adult dosing under supervision.
Side Effects
Common Side Effects
Application-site irritation (burning/stinging), erythema/redness, peeling/desquamation, and dryness.
Safety & Warnings
Warnings & Precautions
For external use only; avoid eyes and mucous membranes; do not apply to broken/infected/inflamed skin; avoid use on large areas, under occlusion, or for prolonged periods (higher systemic absorption risk), especially in children; stop if excessive irritation/allergy or salicylism symptoms occur; use caution in aspirin/salicylate sensitivity.
Age Restriction
Not recommended in children <2 years; use in ≥2 years only with caution and limited area/duration.
Driving Warning
Safe
Drug Interactions
Food Interaction
No clinically relevant food interactions (topical product).
Special Populations
Children
Not recommended in children under 2 years. In children 2-12 years: use with caution, limit application area, avoid occlusion; lower concentrations (2-5%) preferred. Children over 12 years: standard adult dosing under supervision.
Elderly
Use with caution; apply to limited areas, avoid occlusion, and monitor for signs of systemic salicylate toxicity due to potential for increased percutaneous absorption and reduced renal clearance.
Liver Impairment
No specific dose adjustment established; use caution in significant hepatic impairment and avoid large-area or prolonged/occlusive use.
Storage & Patient Advice
Patient Counseling
Topical use only (salicylic acid 10% ointment). Apply a thin layer to the affected area only; avoid eyes, mouth, mucous membranes, and healthy surrounding skin. Do not apply to broken, inflamed, infected skin unless advised by a clinician. Avoid use on large body areas or under occlusion/tight bandages unless directed (increases systemic absorption). Wash hands after application (unless treating hands). Mild stinging/peeling/redness can occur; stop and seek medical advice if severe irritation/allergy occurs or if symptoms of salicylate toxicity appear (e.g., tinnitus, dizziness, nausea). Keep out of reach of children. Store below 25°C.
Monitoring Requirements
No routine laboratory monitoring for localized use; monitor clinically for excessive local irritation/chemical burn. If used on large areas, broken skin, or under occlusion, monitor for salicylate toxicity (e.g., tinnitus, dizziness, nausea).
Pharmacology
Mechanism of Action
Salicylic acid is a keratolytic that solubilizes intercellular cement in the stratum corneum, decreasing corneocyte cohesion and promoting desquamation/softening of hyperkeratotic skin.
Duration of Effect
Benefit persists only with continued use; hyperkeratotic lesions may recur if the underlying friction/pressure or condition persists after stopping.
Bioavailability
Percutaneous absorption is variable and can be substantial; it increases with higher concentration, damaged/abraded skin, large surface area, prolonged use, and occlusion (systemic absorption has been reported to range from low to >50% under enhanced conditions).
Excretion
Renal-excreted mainly as salicyluric acid and salicyl glucuronides with a small fraction as unchanged salicylic acid; urinary pH affects clearance.
Product Information
Composition per Dose
Each 1g of ointment contains: 100mg Salicylic Acid (10% w/w).
Skin Condition
Psoriasis, Acne, Fungal, General Hyperkeratosis
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