IsoSoft

Approved and Clinically Accepted Indications:

• Dry Skin Conditions (e.g., Xerosis, Eczema, Ichthyosis, Psoriasis):
  Used as an emollient to hydrate, soothe, and protect dry or scaly skin by forming a barrier to prevent moisture loss.
• Seborrheic Dermatitis and Infantile Cradle Cap:
  Helps loosen and remove scalp scales and soften affected areas.
• Pre- and Post-Procedure Skin Antisepsis:
  Provides antiseptic cleansing of the skin before minor procedures or dressing changes, reducing microbial load.
• Minor Cuts, Grazes, Insect Bites, and Irritations:
  Aids in preventing infection and soothing skin discomfort while maintaining moisture.
• Fungal Infections (as adjunctive therapy):
  May be used to assist in softening and cleansing affected skin when combined with antifungal therapy.

Adults and Elderly:

• Topical Application: Apply a thin layer to the affected area 2 to 3 times daily or as needed.
• Scalp Use (Cradle Cap/Seborrhea): Massage gently into the scalp, leave on for several hours or overnight, and then wash off with a mild shampoo.

Pediatrics:

• Safe in children under supervision.
• For infants with cradle cap, apply sparingly to the scalp and gently remove softened scales after a few hours.

Renal/Hepatic Impairment:

• No dosage adjustment necessary due to minimal systemic absorption.

Route:

• Topical use only. Avoid contact with eyes, mucous membranes, or deep wounds.

• Liquid Paraffin acts as an occlusive emollient that forms a hydrophobic layer over the skin, preventing transepidermal water loss and restoring skin hydration.
• Benzalkonium Chloride is a quaternary ammonium compound with antimicrobial properties that disrupts microbial membranes, providing antiseptic protection.
• Chlorhexidine is a broad-spectrum antimicrobial agent that binds to the bacterial cell wall, increasing permeability and leading to cell death.
• Isopropyl Myristate acts as a skin-penetrating agent that helps enhance the absorption of other components and also exhibits mild emollient properties.

Together, the combination offers both skin moisturization and antimicrobial action, suitable for managing dry, irritated, or potentially contaminated skin.

• Absorption: Minimal systemic absorption when applied topically to intact skin.
• Distribution: Limited to the stratum corneum and superficial layers of the skin.
• Metabolism: Not significantly metabolized systemically; acts locally.
• Excretion: Any systemically absorbed components (minor amounts) are likely excreted renally.
• Onset of Action: Emollient and soothing effects are typically observed within minutes of application.

• Pregnancy:
  No FDA pregnancy category assigned for topical combination products. Individual components are considered safe when used externally and not applied to large surface areas or broken skin.
• Lactation:
  Safe during breastfeeding when applied externally and not near the breast or nipple area. Avoid infant exposure through direct contact.
• Caution:
  Avoid prolonged use over large areas during pregnancy or lactation without medical advice.

• Primary Class: Topical Emollient and Antiseptic
• Subclass: Moisturizing antiseptic preparation with barrier-repair and skin-softening properties

• Known hypersensitivity to liquid paraffin, benzalkonium chloride, chlorhexidine, isopropyl myristate, or any excipients
• Application to broken, inflamed, or weeping skin without medical supervision
• Use in deep wounds or surgical incisions
• Ocular application or contact with mucous membranes

• Avoid contact with eyes, inner ears, mucosal surfaces, and open wounds.
• Flammability Warning: Liquid paraffin is flammable; keep away from naked flames, lit cigarettes, or sources of heat—especially when used with dressings or clothing.
• Skin Sensitization: Discontinue use if redness, rash, or irritation develops.
• Prolonged Use: Not recommended over large skin areas without medical supervision.
• Ingestion Warning: For external use only; ingestion can be harmful or toxic, especially in children.

Common (Local):

• Mild stinging, burning, or redness at the site of application
• Skin dryness or oiliness (depending on formulation and skin type)

Uncommon:

• Contact dermatitis or allergic rash
• Folliculitis with excessive or prolonged use

Rare but Serious:

• Severe hypersensitivity reactions (e.g., urticaria, swelling)
• Eye irritation if accidentally exposed

Severity & Timing:

• Reactions are usually mild, self-limiting, and occur shortly after application. Severe effects are rare but warrant discontinuation and medical consultation.

• No known significant systemic drug interactions due to topical application and limited absorption.
• Avoid use with other topical antiseptics or detergents, which may inactivate chlorhexidine or cause irritation.
• No interactions with CYP450 enzyme systems are reported or expected.

• Recent safety alerts from dermatology and burn units have emphasized fire risks related to paraffin-based skin products on dressings and fabrics.
• Clinical preference has shifted toward non-alcohol-based antiseptic combinations with moisturizing effects for patients with eczema or frequent handwashing needs.
• Combination formulations with chlorhexidine and emollients are increasingly used in pre-procedural hygiene, particularly in long-term care and wound care settings.

• Temperature: Store below 25°C (77°F) in a cool, dry place.
• Light Protection: Protect from direct sunlight.
• Humidity: Keep container tightly closed to avoid contamination.
• Handling Precautions:
• Flammable: Keep away from open flames and heat sources.
• Do not freeze.
• Ensure the cap is replaced after each use to maintain product integrity.