White soft paraffin + Liquid paraffin + Wool alcohol

Approved Indications:

• Dry skin conditions: Including xerosis, ichthyosis, and general skin dehydration.
• Eczema and dermatitis: As a supportive emollient therapy in atopic dermatitis, contact dermatitis, and seborrheic dermatitis.
• Psoriasis: To reduce scaling, dryness, and itchiness.
• Lichenified skin disorders: As a moisture barrier and softener.
• Ichthyosis vulgaris and keratosis pilaris: To improve skin hydration and texture.
• Diaper rash (in infants): As a protective barrier.
• Chapped skin and lips: Due to cold weather or environmental exposure.

Off-label or Supportive Uses:

• Post-procedure dermatologic care: Moisturization after laser therapy, dermabrasion, or chemical peels.
• Radiation dermatitis: As a barrier and moisturizer in patients receiving radiotherapy.

Route of Administration: Topical

Adults and Elderly:

• Apply a thin layer to the affected skin areas 2 to 3 times daily or as required.
• Frequency can be increased in cases of severe dryness, especially after bathing or handwashing.

Pediatrics:

• Safe for use in infants and children.
• Apply sparingly to affected areas 2 times daily, especially after bathing.

Special Populations:

• Renal or hepatic impairment: No dose adjustment required, as systemic absorption is negligible.
• Geriatric use: Same as adults, with extra caution to avoid slipperiness post-application.

Application Notes:

• Apply to clean, dry skin.
• Rub gently until absorbed.
• Avoid contact with eyes and mucous membranes.
• Avoid application to open wounds unless directed by a physician.

White Soft Paraffin and Liquid Paraffin act as occlusive and emollient agents that create a semi-permeable lipid barrier on the skin surface, preventing transepidermal water loss (TEWL) and locking in moisture. Wool Alcohol (derived from lanolin) has additional emulsifying properties that improve skin barrier restoration and hydration. Together, these agents restore the hydrolipidic film of the epidermis, soften keratinized skin, and promote skin elasticity and repair.

• Absorption: Minimal systemic absorption through intact skin. Slight dermal absorption may occur with prolonged use on broken skin.
• Distribution: Remains localized to the skin surface and superficial layers of the stratum corneum.
• Metabolism: Not significantly metabolized due to minimal absorption.
• Excretion: Not systemically excreted; mostly eliminated by washing off or natural skin exfoliation.

• Pregnancy: Considered safe for use during pregnancy. Not assigned an FDA pregnancy category as it is a non-systemic topical preparation. No teratogenic effects have been reported.
• Lactation: Safe during breastfeeding. It is recommended to avoid application to the nipple area immediately before feeding. Wash off any residual product from nipples before nursing to prevent infant ingestion.
• Caution: Avoid extensive application on broken skin during pregnancy unless under medical supervision.

• Primary Class: Emollient and Skin Protectant
• Subclass: Occlusive Moisturizer
• Type: Non-pharmacologically active topical barrier preparation

• Known hypersensitivity or allergy to white soft paraffin, liquid paraffin, wool alcohol, or any lanolin-derived substances.
• Application on infected, weeping, or severely broken skin unless under medical advice.
• Use in patients with known lanolin allergy (wool alcohol sensitivity).

• Fire hazard: Paraffin-based products are flammable. Avoid use near naked flames, cigarettes, or high-heat sources. Clothing or bedding contaminated with the product may catch fire easily.
• Occlusion risk: Excessive application may cause folliculitis or occlusion-related skin reactions.
• High-risk groups: Patients with a history of contact dermatitis or sensitivity to wool-derived products (wool alcohol).
• Monitoring: Monitor for signs of contact allergy (itching, rash, erythema). Discontinue if any hypersensitivity reactions occur.
• Slippery skin/clothing: May increase fall risk, especially in the elderly, due to greasy residue on skin or flooring.

Common (Local Reactions):

• Mild skin irritation
• Itching (pruritus)
• Burning or stinging sensation
• Greasy residue on skin

Less Common:

• Acneiform eruptions
• Folliculitis (especially with prolonged occlusion)

Rare but Serious:

• Contact dermatitis (especially due to wool alcohol)
• Hypersensitivity reactions (rash, swelling, urticaria)

Onset & Severity:

• Most side effects are mild and occur early after application. Severity increases with overuse or occlusion.

• Drug-drug: No significant systemic interactions reported due to minimal systemic absorption.
• Drug-cosmetic: May reduce the effectiveness of topical corticosteroids or antimicrobials if applied simultaneously without spacing.
• Enzyme systems: Not metabolized by CYP450; no known effect on hepatic enzymes.
• Drug-device: Greasy film may impair adhesion of medical dressings or tapes.

• MHRA (UK) and EMA have issued safety alerts emphasizing fire risk associated with paraffin-based skin products, especially with smoking or open flames.
• Updated labeling includes clear flammability warnings on all paraffin-containing emollient packaging.
• Clinical guidelines now recommend routine counseling on safe use practices (e.g., laundering clothes, avoiding heat sources) when prescribing.

• Temperature: Store at below 25°C. Do not freeze.
• Humidity/Light: Keep container tightly closed and protected from moisture and direct sunlight.
• Handling: Use clean hands or a sterile spatula to dispense. Do not use if the product changes color, texture, or smell.
• Container type: Store in a sealed, airtight jar or tube. Do not transfer contents to other containers.
• Shelf-life: Usually 24–36 months from manufacturing date if unopened. Check packaging for exact expiry.