Light kaolin + Silver sulfadiazine + Calcium gluconate + Butane propellant

Approved Indications:

• First- and second-degree burns: Provides immediate topical relief, antimicrobial protection, and aids in wound healing.
• Sunburns: Offers soothing and anti-inflammatory effects while preventing secondary infections.
• Superficial wounds and abrasions: Promotes healing and prevents microbial colonization.
• Chemical burns (e.g., hydrofluoric acid exposure): Calcium gluconate binds free fluoride ions, reducing tissue damage and systemic toxicity.
• Burn wound infection prevention: Silver sulfadiazine reduces microbial contamination and prevents infection in burn sites.

Clinically Accepted Off-Label Uses:

• Radiation-induced dermatitis: Occasionally used for its soothing, anti-inflammatory, and antimicrobial properties.
• Donor or graft site care: Used in certain clinical settings to prevent microbial contamination and facilitate healing.

Adults and Elderly:

• Apply a thin, even layer of spray to the affected area from a distance of 10–15 cm, 1 to 2 times daily, or as directed by a healthcare provider.

Pediatric Use:

• Children over 2 months: Safe when used in small areas under supervision.
• Neonates and premature infants: Use with caution due to the potential risk of systemic silver absorption and toxicity.

Renal and Hepatic Impairment:

• Use cautiously in patients with renal or hepatic impairment, as systemic absorption of silver may be increased with extensive skin application.

Administration Route:

• Topical (aerosol spray)

Treatment Duration:

• Continue until wounds are re-epithelialized or as per physician recommendation.

Important Instructions:

• Clean and dry the affected area before application.
• Shake the can well before use.
• Avoid contact with eyes, mucous membranes, and inhalation of spray.
• Do not apply near open flames or heat sources due to the flammable propellant.

• Silver Sulfadiazine exerts broad-spectrum antimicrobial activity by releasing silver ions that disrupt bacterial cell walls and inhibit DNA replication. This prevents and controls infection in burns and wounds.
• Light Kaolin serves as a skin protectant and absorbent. It forms a physical barrier that soothes the skin, absorbs exudate, and protects against external irritants.
• Calcium Gluconate acts by chelating fluoride ions in hydrofluoric acid burns, neutralizing them to prevent deep tissue penetration and systemic toxicity.
• Butane Propellant has no pharmacological action but enables uniform aerosol delivery of the active ingredients.

• Absorption:
• Silver sulfadiazine is minimally absorbed through intact skin but may be absorbed systemically from large, open, or damaged skin areas.
• Calcium gluconate and kaolin are primarily active at the site of application with negligible systemic absorption.
• Distribution:
• Absorbed silver may distribute to the liver and kidneys.
• Metabolism:
• Sulfadiazine is metabolized in the liver.
• Elimination:
• Silver and sulfadiazine are primarily excreted via the kidneys.
• Bioavailability:
• Systemic bioavailability is clinically insignificant with proper topical use.
• Half-life:
• Not applicable for topical agents in typical use.
• Onset of Action:
• Antibacterial and soothing effects begin within minutes of application.

• Pregnancy:
• FDA Category C. Use is not recommended, especially during the third trimester, due to the risk of kernicterus in newborns from sulfonamides.
• Lactation:
• Topical use over limited skin areas is generally safe during breastfeeding. However, avoid infant exposure to treated skin and monitor for signs of hypersensitivity.

Clinical Recommendation:
Use with caution during pregnancy and lactation. Avoid prolonged use over large areas.

• Primary Class: Topical Antibacterial and Burn Treatment Agent
• Subclass: Silver-Based Antimicrobial + Skin Protectant + Fluoride-Binding Agent

• Known hypersensitivity to silver, sulfonamides, calcium gluconate, kaolin, or any other component of the formulation
• Neonates and premature infants (due to risk of silver toxicity and kernicterus)
• Severe hepatic or renal impairment
• Concurrent use with enzymatic wound debriding agents (e.g., collagenase)

• Renal or hepatic dysfunction: Increased risk of silver accumulation and systemic toxicity.
• Hypersensitivity reactions: Monitor for signs such as rash, itching, or systemic symptoms; discontinue if they occur.
• Flammability risk: Do not use near flames or while smoking.
• Photosensitivity and skin discoloration: Temporary gray discoloration may occur due to silver deposition in the skin.
• Pediatric use: Use cautiously in infants and only under medical supervision.

Common Side Effects:

• Mild burning or stinging at the site of application
• Temporary gray or white discoloration of the skin
• Dryness or peeling of skin

Less Common:

• Contact dermatitis
• Itching or redness

Serious (Rare) Side Effects:

• Argyria (irreversible bluish-gray skin discoloration from long-term silver exposure)
• Leukopenia
• Allergic reactions (including anaphylaxis or Stevens-Johnson syndrome)
• Hypercalcemia (in case of significant systemic calcium absorption, very rare)

• Silver sulfadiazine:
• Incompatible with enzymatic debriding agents (e.g., trypsin, collagenase).
• May interact with other topical sulfonamide products if used concurrently.
• Calcium gluconate:
• May affect absorption of other calcium-sensitive agents if applied together.
• CYP450 involvement: Not significant for topical use.
• Drug-food/alcohol interactions: Not applicable.

• Silver sulfadiazine remains widely used for burn care, though some guidelines favor short-term use due to potential delays in epithelialization with long-term use.
• Calcium gluconate continues to be a critical component in managing hydrofluoric acid burns.
• No major updates in regulatory status, dosing, or safety warnings by the FDA or WHO as of the latest clinical review.

• Store below 25°C (77°F)
• Do not freeze
• Protect from direct sunlight and heat
• Highly flammable: Keep away from heat, sparks, open flames, or hot surfaces.
• Do not puncture or incinerate the container, even when empty.
• Shake well before use
• Keep out of reach of children