Zinc Oxide [For diaper rash]

Approved Uses:

• Treatment and prevention of diaper rash: Acts as a skin protectant to prevent and heal mild to moderate irritant contact dermatitis in infants and toddlers due to prolonged exposure to moisture, urine, and feces.
• Minor skin irritations: Cuts, scrapes, burns, chafed skin.

Clinically Accepted Off-label Use:

• Moisture-associated skin damage (MASD) in elderly or incontinent adults (e.g., incontinence-associated dermatitis).
• Barrier protection in patients at risk for pressure ulcers or friction injury.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Infants and Children (up to 12 years):

• Apply liberally to clean, dry skin with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged.

Adults (off-label uses):

• Apply 1–3 times daily to affected area as needed for skin protection or rash prevention.

Application Instructions:

• Clean affected area gently and allow to dry completely before application.
• Use a thick layer to ensure effective barrier formation.
• For prevention, use regularly during each diaper change.

Special Populations:

• Geriatric: Safe for use on fragile skin in the elderly when used as a moisture barrier.
• Renal/Hepatic Impairment: No adjustments necessary; not systemically absorbed.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Zinc oxide acts as a physical barrier that protects the skin from irritants such as moisture, urine, and feces. It provides astringent, antiseptic, and mild anti-inflammatory effects by forming an occlusive layer over the skin that reduces transepidermal water loss and friction. It also has mild antimicrobial activity, promoting an environment that supports skin healing and prevents further breakdown.

Absorption:

• Minimal to no systemic absorption when applied topically to intact or mildly inflamed skin.
• Increased absorption possible if applied over large areas of broken skin, open wounds, or mucous membranes.

Distribution, Metabolism, Excretion:

• Not systemically distributed or metabolized under normal conditions.
• Excretion data not relevant due to lack of systemic absorption.

Pregnancy:

• Generally recognized as safe (GRAS) for topical use in pregnancy. No known teratogenic effects.
• Minimal to no systemic absorption.

Lactation:

• Safe during breastfeeding when used as directed.
• Avoid application to the breast or nipple area unless under physician guidance.

• Primary: Skin Protectant
• Subclass: Topical barrier agent / Inorganic compound (zinc derivative)

• Hypersensitivity to zinc oxide or any formulation components
• Application to deep puncture wounds or serious burns unless directed by a physician
• Avoid use on infected or oozing lesions without medical supervision

• For external use only – avoid contact with eyes and mucous membranes.
• Discontinue if irritation, rash, or allergic reaction occurs.
• Not a treatment for fungal or bacterial infections – avoid misuse on infected areas.
• If symptoms worsen or persist >7 days, consult a physician.
• Do not use on large, raw, or blistered skin without medical advice.

Common (rare in appropriate use):

• Mild stinging or itching at the application site
• Skin whitening (due to zinc oxide paste)

Rare/Serious Reactions:

• Allergic contact dermatitis
• Local irritation with prolonged or excessive use
• Worsening of underlying skin infection if misused

Timing & Dose-Dependence:

• Reactions typically mild and localized; more likely with broken skin or long-term use without cleansing.

• No known significant systemic drug interactions due to minimal absorption.
• Topical interaction potential:
• May reduce absorption of other topicals if layered (e.g., corticosteroids or antimicrobials) — apply separately and allow sufficient drying time.
• No CYP enzyme involvement.

• FDA labeling reaffirmed that zinc oxide is a Category I active ingredient (safe and effective) in over-the-counter skin protectant drug products for diaper rash.
• AAP and pediatric dermatology guidelines continue to support barrier creams containing zinc oxide as first-line therapy and prevention for irritant diaper dermatitis.
• Updated formulations now include fragrance-free and hypoallergenic options to minimize sensitivity risk in neonates.

• Store at 15–30°C (59–86°F)
• Protect from excessive heat, light, and moisture
• Do not freeze
• Tightly close container after use to prevent drying
• No shaking, mixing, or reconstitution needed