Miconazole Nitrate + Zinc Oxide + White Soft Paraffin

Approved Indications:
This combination is used topically for the treatment and prevention of fungal infections accompanied by skin irritation or diaper rash, particularly in sensitive or moist areas.

• Diaper dermatitis (diaper rash) complicated or at risk of Candida albicans infection
• Irritant or allergic contact dermatitis in infants, with fungal colonization
• Candidal intertrigo (e.g., under breasts, groin, axillae)
• Superficial fungal infections of the skin with co-existing inflammation or high moisture
• Prevention of fungal recurrence in skin folds

Off-label/Clinically Accepted Uses:

• Barrier protection in elderly patients with incontinence-associated dermatitis
• Prophylactic antifungal barrier in bedridden or immobile patients at risk of skin maceration

Formulation: Topical cream or ointment

Adults, Elderly, and Children (including infants):

• Apply a thin layer to the affected area 2–3 times daily or at every diaper change (in infants)
• Ensure the skin is clean and dry before application
• Continue treatment for at least 3–5 days after symptoms resolve
• For diaper rash: Apply generously over the diaper area and in skin folds during each diaper change
• Duration: Typically 7–10 days, but may be extended up to 14 days based on clinical response

Special Populations:

• Neonates and Infants: Safe when used appropriately under medical guidance
• Renal/Hepatic Impairment: No dose adjustment needed due to minimal systemic absorption

This triple combination provides synergistic action:

• Miconazole Nitrate: An imidazole antifungal that inhibits ergosterol synthesis in fungal cell membranes by blocking 14α-demethylase, leading to membrane disruption and fungal cell death. Effective against Candida albicans and other dermatophytes.
• Zinc Oxide: An astringent and skin protectant that forms a physical barrier, reducing moisture, irritation, and bacterial growth. It also exhibits mild antiseptic and anti-inflammatory effects.
• White Soft Paraffin: An occlusive emollient that softens and hydrates the skin while creating a protective barrier to retain moisture and shield against irritants.

Together, these agents provide antifungal action, skin protection, and soothing relief from inflammation and irritation.

• Miconazole Nitrate:
  • Absorption: Minimal systemic absorption via intact skin
  • Distribution: Highly protein-bound if absorbed
  • Metabolism: Hepatic (oxidative pathways)
  • Elimination: Fecal route (biliary excretion)
  • Half-life: Approx. 24 hours (for absorbed fraction)
• Zinc Oxide & White Soft Paraffin:
  • Not systemically absorbed in significant amounts
  • Act locally on the skin surface
  • No metabolism or active elimination pathways required

• Pregnancy:
  • FDA Category C (based on miconazole component)
  • Topical use of this combination is considered safe during pregnancy when used appropriately
  • Avoid prolonged use or application over large areas
• Lactation:
  • Minimal to no systemic absorption of ingredients
  • Safe for use during breastfeeding
  • Avoid application on or near the breast area if nursing

• Primary Class:
  • Topical Antifungal + Skin Protectant Combination
• Subclasses:
  • Miconazole – Imidazole antifungal
  • Zinc Oxide – Inorganic skin protectant and astringent
  • White Soft Paraffin – Occlusive emollient/moisturizer

• Known hypersensitivity to miconazole, zinc oxide, white soft paraffin, or any other component of the formulation
• Use on deep or puncture wounds, serious burns, or extensively broken/infected skin
• Ophthalmic use (avoid contact with eyes)

• Allergic reactions: Rare, but discontinue if rash, swelling, or itching worsens
• Superinfection: Discontinue if secondary bacterial infection develops
• Occlusive use: Prolonged use under occlusive dressings or diapers may increase systemic absorption; use with caution
• Avoid contact with eyes, mouth, or mucous membranes
• Use in neonates: Safe when used under medical supervision and not overused

Common (Topical)

• Mild burning, stinging, redness, or skin irritation
• Dryness or maceration at application site

Less Common

• Skin rash or allergic dermatitis
• White discoloration or buildup due to zinc oxide residue

Rare but Serious

• Anaphylaxis or angioedema (very rare)
• Secondary bacterial infection with prolonged occlusive use

Onset: Most effects occur early, usually within the first few applications
Severity: Generally mild and reversible upon discontinuation

• Warfarin:
  • Miconazole may potentiate warfarin's effects due to CYP2C9 inhibition, even from topical use
  • Monitor INR closely in patients on anticoagulation
• No known interactions with zinc oxide or white soft paraffin
• No significant drug-food or drug-alcohol interactions relevant to topical use

• Dermatology and Pediatric Guidelines continue to support use of combination antifungal-barrier products in managing diaper dermatitis complicated by candidiasis
• NICE and WHO emphasize barrier protection in high-risk skin-fold areas to prevent moisture-associated skin damage
• Recent clinical emphasis is placed on short-term use (≤2 weeks) to avoid skin maceration and potential overuse of antifungals

• Recommended storage temperature:
  • 15°C to 30°C (59°F to 86°F)
  • Protect from excessive heat, direct sunlight, and moisture
  • Keep container tightly closed
  • Do not refrigerate or freeze
• Handling precautions:
  • Use clean, dry hands or applicators
  • Avoid sharing the product
  • Discard after expiration or if contamination is suspected