Composition:

• Active Ingredient: Each gram contains Permethrin 50 mg (5% w/w).
• Inactive Ingredients: May include butylated hydroxytoluene, carbomer, coconut oil, glycerin, glyceryl stearate, isopropyl myristate, lanolin alcohols, light mineral oil, polyoxyethylene cetyl ethers, purified water, sodium hydroxide, and other excipients depending on the formulation (e.g., propylene glycol, stearyl alcohol, cetyl alcohol, polysorbate 60). Specific inactive ingredients may vary by manufacturer.

Description: Scabifine PMR Cream is a topical scabicidal agent designed to treat infestations caused by Sarcoptes scabiei (scabies). It is a white to off-white, vanishing cream that disappears when rubbed gently into the skin. Permethrin, a synthetic pyrethroid, is the active ingredient, which works by disrupting the sodium channel current in the nerve cell membranes of mites, leading to paralysis and death of the parasites and their eggs.

Indications:

• Treatment of scabies in adults and children aged 2 months and older.
• May also be used to treat crab lice (pediculosis pubis) in adults, as prescribed by a healthcare provider.

Dosage and Administration:

• For Scabies: Apply a thin layer of the cream to clean, dry, and cool skin from the neck down to the soles of the feet, including skin folds (e.g., between fingers and toes, underarms, groin). For infants, young children (2 months to 2 years), and elderly patients (>65 years), the cream should also be applied to the scalp, face, ears, and neck, avoiding the eyes and mouth. Leave on for 8–14 hours (e.g., overnight), then wash off by showering or bathing. A single application cures approximately 90% of cases. If live mites are observed 14 days post-treatment, a second application may be needed after at least 7 days.
• For Crab Lice: Apply to affected areas (e.g., pubic region, inner thighs). Leave on for 8–12 hours before washing off.
• Dosage Guidelines:
  • Adults and children >12 years: Up to 30 g (one 30 g tube) per application.
  • Children 6–12 years: Up to 15 g (½ tube).
  • Children 2–5 years: Up to 7.5 g (¼ tube).
  • Infants (2 months–2 years): Use under medical supervision.
• Reapply to hands if washed within 8 hours of application. Ensure close contacts (e.g., family members, sexual partners) are treated simultaneously to prevent reinfestation. Wash all bedding, towels, and clothing in hot water.

Contraindications:

• Hypersensitivity to permethrin, synthetic pyrethroids, pyrethrins, chrysanthemums, or any excipients (e.g., lanolin alcohols, methyl parahydroxybenzoate).
• Not recommended for use on broken skin, mucous membranes, or near the eyes unless specifically directed.

Precautions:

• For external use only. Avoid contact with eyes, nose, mouth, or vagina. If contact occurs, rinse thoroughly with water.
• Not recommended for children under 2 months. Use in children aged 2–23 months requires medical supervision.
• Pregnant or breastfeeding women should consult a doctor, though permethrin is considered safe with minimal absorption (<2%).
• Patients with ragweed or chrysanthemum allergies should use with caution due to potential allergic reactions.
• Do not apply immediately after a hot bath or shower; allow skin to cool first.
• Carers applying the cream should wear gloves to avoid skin irritation.
• Persistent itching post-treatment (up to 4 weeks) is normal and does not indicate treatment failure unless live mites are present.

Side Effects:

• Common: Mild burning, stinging, itching, or redness at the application site, which may temporarily worsen due to scabies infestation. These usually resolve within 4 weeks.
• Rare: Severe allergic reactions (e.g., rash, swelling, difficulty breathing), edema, or persistent irritation. Discontinue use and seek medical attention if these occur.
• Very mild eye irritation if contact occurs. Flush with water immediately.

Storage:

• Store at room temperature (20–25°C / 68–77°F), with excursions permitted between 15–30°C (59–86°F).
• Keep out of reach of children.