Calamine

Approved Indications:

• Relief of pruritus due to:
• Insect bites or stings
• Chickenpox or measles rash
• Allergic skin reactions (e.g., contact dermatitis)
• Minor burns and sunburn
• Diaper rash in infants
• Heat rash (miliaria rubra)
• Mild eczema or atopic dermatitis
• Minor skin abrasions or chafing
• Irritation caused by poison ivy, poison oak, or poison sumac

Clinically Accepted Off-label Uses:

• Supportive therapy in viral exanthems such as varicella (for soothing vesicular lesions)
• Symptomatic relief in urticaria or idiopathic itching
• Preventive barrier in areas prone to friction (intertrigo management)

Dosage Form: Lotion, cream, or ointment for topical use

Adults:

• Apply a thin layer to the affected area 2–4 times daily or as directed by a physician.

Children:

• Safe for topical use. Apply a thin layer 2–3 times daily on affected areas.
• For diaper rash, apply after every diaper change, especially at bedtime.

Infants:

• Use under physician supervision in infants under 6 months.
• For diaper rash, apply gently to clean, dry skin with each diaper change.

Elderly:

• Use the same adult dosing. Monitor for excessive dryness due to thinner skin.

Special Populations:

• Renal/Hepatic impairment: No dosage adjustment needed due to negligible systemic absorption.

Route of Administration: Topical (external use only)

• Calamine acts as a mild astringent and antipruritic. It soothes itching and irritation by forming a protective layer over the skin, reducing fluid oozing.
• Zinc Oxide serves as a skin protectant and mild anti-inflammatory agent, providing antiseptic action and helping in wound healing.
• Glycerine is a humectant, drawing moisture into the skin, preventing dryness, and maintaining skin hydration.

Together, this combination protects irritated skin, reduces itching, and promotes a moist environment for healing.

• Absorption: Negligible systemic absorption through intact skin
• Distribution: Not systemically distributed
• Metabolism: Not metabolized (topical barrier action)
• Excretion: Not applicable
• Onset of Action: Soothing effect usually begins within minutes
• Half-life: Not applicable due to local action only

Pregnancy:

• Considered safe for topical use during all trimesters of pregnancy.
• Classified as Pregnancy Category A (topical use) in many regions.

Lactation:

• Safe for nursing mothers.
• Avoid application directly to the nipple area to prevent infant ingestion.
• No known risk when used appropriately on intact skin.

• Dermatological Agent
• Subclass: Skin Protectant / Antipruritic / Astringent / Moisturizer Combination

• Hypersensitivity to calamine, zinc oxide, glycerine, or any excipients in the formulation
• Open wounds or deep skin infections unless under physician guidance
• Application to eyes, inside the mouth, or genital mucosa

• For external use only
• Avoid eye contact; rinse thoroughly with water if accidental exposure occurs
• Do not apply on broken, bleeding, or severely inflamed skin
• Discontinue use if rash, irritation, or burning develops
• Do not cover the application area with tight dressings or bandages unless instructed
• If symptoms persist for more than 7 days, consult a healthcare provider

Common (usually mild):

• Temporary dryness or white residue
• Mild stinging or cooling on initial application

Uncommon:

• Localized redness or irritation
• Skin tightness

Rare but Serious:

• Allergic contact dermatitis
• Rash or swelling due to hypersensitivity

• No known significant systemic drug interactions due to topical, non-absorptive action
• Avoid simultaneous application with other topical medications, especially corticosteroids or irritants, unless advised by a doctor
• No known food or oral medication interactions

• Continues to be recommended in pediatric and dermatological guidelines for managing mild skin irritation and pruritus
• Widely recognized in international skin care protocols for infant diaper dermatitis prevention
• No significant changes in global or regulatory status in recent updates

• Store at room temperature below 25°C (77°F)
• Protect from excessive heat, sunlight, and moisture
• Keep the container tightly closed after each use
• Do not freeze
• Keep out of reach of children