Neiva

 50%+50% Ointment
Pharmik Laboratories Ltd.

10 gm tube: ৳ 75.00

25 gm tube: ৳ 100.00

180 ml container: ৳ 650.00

Indications

Approved Indications:

  • Dry Skin Conditions:
    • Xerosis (dry, cracked skin)
    • Ichthyosis
    • Atopic dermatitis (mild to moderate; used as a supportive treatment)
    • Senile pruritus
  • Chronic Eczematous Disorders:
    • Eczema (all types) for hydration and flare prevention
    • Contact dermatitis (irritant or allergic)
    • Nummular eczema
    • Asteatotic eczema
  • Psoriasis:
    • For scale removal and hydration, especially in chronic plaque psoriasis
  • Skin Barrier Protection:
    • Diabetic dry foot skin
    • Prevention of pressure ulcers (as barrier emollient)
    • Peristomal skin protection

Clinically Accepted Off-Label Uses:

  • Post-procedure skin repair:
    • After laser resurfacing, chemical peels, or dermabrasion
  • Lip dryness (as a lip protectant)
  • Cracked heels and callused feet
  • Emollient under occlusion in lichen simplex chronicus
Dosage & Administration

Route: Topical (cutaneous use only)

Adults:

  • Apply liberally 2–4 times daily, or as often as needed to affected areas
  • Especially effective when applied immediately after bathing

Children & Infants:

  • Apply a thin layer 2–3 times daily
  • Safe for use in infants over 1 month; suitable for nappy rash-related dryness (not on broken skin)

Elderly:

  • Same as adult dosing; may require more frequent application due to age-related skin thinning

Renal & Hepatic Impairment:

  • No dose adjustment required due to minimal systemic absorption

Administration Guidelines:

  • Apply to clean, dry skin
  • Use gentle strokes, do not rub vigorously
  • Reapply after handwashing or bathing
  • If used with topical steroids, apply at different times (usually steroid first, emollient 30 minutes later)
Mechanism of Action (MOA)

White Soft Paraffin and Liquid Paraffin work together as occlusive emollients. They form a semi-occlusive film over the stratum corneum, significantly reducing transepidermal water loss (TEWL). By retaining moisture within the skin, they help restore skin hydration, elasticity, and barrier function. These agents fill in spaces between desquamating skin cells and provide a smooth surface, reducing flakiness and itching. The occlusion also supports faster healing of micro-cracks in dry, irritated skin.

Pharmacokinetics
  • Absorption: Minimal to negligible systemic absorption through intact skin
  • Distribution: Remains localized within the outer epidermal layer
  • Metabolism: Not metabolized systemically; inert hydrocarbons are not enzymatically degraded
  • Excretion: Removed via skin washing or natural desquamation
  • Bioavailability: Not systemically bioavailable
  • Onset of action: Immediate after application
  • Duration of action: 4 to 12 hours depending on ambient humidity and skin condition
Pregnancy Category & Lactation
  • Pregnancy: Considered safe for use during pregnancy. No known teratogenic or systemic effects due to topical use.
  • Lactation: Compatible with breastfeeding. If applied to nipples, excess should be wiped off before nursing to avoid infant ingestion.
  • Caution: Avoid application on broken skin near nipples in lactating mothers.
Therapeutic Class
  • Primary Class: Emollient / Moisturizer
  • Subclass: Occlusive-type emollient
  • Generation: Traditional barrier-forming topical emollient
Contraindications
  • Hypersensitivity to white soft paraffin, liquid paraffin, or any excipients
  • Application on infected or weeping skin wounds without medical supervision
  • Avoid use in individuals with known paraffin-related folliculitis
Warnings & Precautions
  • Fire Hazard: White soft paraffin and liquid paraffin are flammable. Keep away from flames, cigarettes, or heat sources during and after application.
  • Occlusion Caution: Over-occlusion can lead to folliculitis or miliaria
  • Slippage Risk: May make floors slippery—especially with foot application
  • Lanolin-free products preferred in patients with known wool alcohol allergy
  • Monitor for:
    • New rashes or worsening dermatitis (possible allergy)
    • Secondary skin infections from excessive barrier occlusion
Side Effects

Common:

  • Greasy feeling at site of application
  • Mild irritation or warmth after application

Less Common:

  • Folliculitis (especially in areas under occlusion like underarms or groin)
  • Acneiform eruptions in sensitive individuals

Rare but Serious:

  • Allergic contact dermatitis
  • Secondary bacterial infection due to excessive occlusion

Timing: Most side effects occur within the first week of application and are mild and reversible

Drug Interactions
  • No systemic drug interactions due to lack of absorption
  • Topical Interaction Risk:
    • May reduce effectiveness of topical corticosteroids or antimicrobials if applied immediately before or after
    • Apply paraffin-based emollients after a gap of at least 30 minutes from active topicals
  • No food, alcohol, or enzyme (CYP450) interactions
Recent Updates or Guidelines
  • 2023–2024 Dermatology Guidelines: Reaffirmed as first-line treatment for all forms of dry skin and eczema in both adults and children
  • MHRA (UK) & EMA Warnings: Emphasis on fire safety labeling due to paraffin flammability risk when soaked into clothes or bedding
  • Formulation Updates: Shift toward paraben-free and lanolin-free versions for sensitive skin
Storage Conditions
  • Temperature: Store between 15°C to 25°C (room temperature)
  • Protection: Keep container tightly closed; protect from direct sunlight and excessive heat
  • Humidity: Avoid storage in high humidity (e.g., bathroom cabinet)
  • Handling: Use clean hands or spatula to dispense product to prevent contamination
  • Flammability Warning: Do not expose clothing, bedding, or dressings containing the product to naked flames
  • No refrigeration or reconstitution required