Hydrocortisone Acetate + Benzyl Benzoate + Bismuth Subgallate + Bismuth Oxide + Balsam Peru + Zinc Oxide

• Topical Skin Disorders
• Inflammatory dermatoses: Eczema, dermatitis, and psoriasis
• Pruritus and mild allergic reactions: Reduces itching and irritation
• Protective and Healing Formulations
• Provides barrier protection for mild irritations, minor burns, or diaper rash
• Helps in wound healing by forming protective coating and reducing secondary infections
• Off-label / Clinically Accepted Uses
• Minor abrasions, fissures, and inflamed areas prone to infection
• Hyperkeratotic or weeping lesions requiring combined anti-inflammatory and protective action

• Topical Administration Only
• Apply a thin layer 1–3 times daily to affected area
• Duration: 7–14 days or as directed by a healthcare professional
• For chronic or severe lesions, re-evaluate after 1–2 weeks
• Special Populations
• Use minimal effective quantity in children
• Avoid application on broken or infected skin unless directed
• Administration Instructions
• Clean and dry affected area before application
• Wash hands after application to avoid contact with eyes or mucous membranes

This combination therapy acts synergistically. Hydrocortisone acetate is a glucocorticoid that suppresses inflammation and immune responses by inhibiting cytokine production and leukocyte migration. Benzyl benzoate acts as a mild antipruritic and antiparasitic agent. Bismuth subgallate and bismuth oxide provide astringent, protective, and mild antiseptic effects. Balsam Peru promotes healing and reduces irritation, while zinc oxide forms a protective barrier, reduces moisture, and has mild anti-inflammatory properties. Together, these components reduce inflammation, itching, and irritation while protecting skin and promoting repair.

• Absorption: Minimal systemic absorption via intact skin; increased absorption through damaged skin
• Distribution: Limited systemic exposure; mainly local effect
• Metabolism: Hydrocortisone acetate metabolized hepatically to active hydrocortisone; other components act locally
• Excretion: Primarily renal for systemically absorbed hydrocortisone metabolites; other components excreted unchanged in feces if not absorbed
• Onset: Hours for hydrocortisone anti-inflammatory effect; immediate for barrier protection by zinc oxide and bismuth compounds
• Duration: Anti-inflammatory effects last 8–12 hours; protective effects persist until removed

• Pregnancy: Topical use considered Category C; avoid large surface areas or prolonged use
• Lactation: Limited data; use caution, particularly for application on breast area; systemic absorption may affect infant minimally

• Primary therapeutic class: Combination topical therapy
• Subclass: Corticosteroid + protective barrier + mild astringent and antipruritic formulation

• Known hypersensitivity to hydrocortisone, bismuth salts, balsam of Peru, zinc oxide, or benzyl benzoate
• Open, infected wounds without professional supervision
• Severe hepatic or renal dysfunction for systemic hydrocortisone absorption risk

• High-risk groups: Pediatric, pregnant, lactating, or immunocompromised patients
• Systemic absorption risk: Avoid prolonged use on large surface areas to prevent corticosteroid side effects
• Allergic reactions: Balsam of Peru can cause contact dermatitis
• Monitoring: Look for signs of skin thinning, irritation, secondary infections, or systemic corticosteroid effects

• Common: Mild burning, stinging, or redness at application site
• Dermatologic: Skin thinning, striae, acneiform eruptions, or hyperpigmentation with prolonged use
• Allergic: Contact dermatitis, pruritus, or rash
• Rare/Serious: Secondary skin infections due to immunosuppressive effect of hydrocortisone; systemic corticosteroid effects are rare with topical use

• Other topical corticosteroids: Increased risk of local or systemic corticosteroid effects
• Systemic CYP3A4 inhibitors or inducers: Minimal interaction unless significant systemic absorption occurs
• Avoid concurrent use of irritating topical agents on the same area unless directed

• Emphasis on short-term topical use to reduce corticosteroid-associated skin atrophy
• Updated labeling highlights risk of sensitization from Balsam of Peru and bismuth salts
• Guidelines recommend avoiding occlusive dressings unless specifically advised, to prevent excessive absorption
• Use in pediatric and pregnant populations should be limited to minimal effective area and duration

• Store at 20°C to 25°C (room temperature)
• Protect from light, moisture, and heat
• Keep tightly closed and out of reach of children
• Avoid freezing
• Topical formulation: check for discoloration, separation, or contamination before use