Softderm

Approved and Clinically Accepted Indications:

• Dry Skin Conditions:
• Xerosis, ichthyosis, atopic dermatitis, contact dermatitis, and eczema.
• Psoriasis for relief of scaling and dryness.
• Barrier Protection:
• Acts as a skin protectant in patients exposed to frequent washing or chemical irritants.
• Helps prevent pressure ulcers in immobile patients.
• Burn and Wound Care:
• Adjunctive use in superficial burns or healing wounds to retain moisture and reduce irritation.
• Hyperkeratotic Skin Disorders:
• Softens thickened skin in conditions like lichen simplex chronicus and chronic eczema.
• Prevention of Diaper Rash:
• Serves as a moisture barrier in infants and incontinent patients.

Route: Topical

Adults and Elderly:

• Apply a thin layer to the affected area 2 to 4 times daily or as directed by a physician.
• Best applied immediately after bathing or washing to lock in moisture.

Pediatric Use:

• Safe in children; apply 2 to 3 times daily under adult supervision.
• Avoid contact with eyes, mouth, and mucous membranes.

Special Populations:

• Renal or Hepatic Impairment: No dose adjustment required. Not systemically absorbed.
• Pregnancy and Lactation: Safe for external use; avoid application to the breast area before nursing.

Duration of Use: Continue as long as needed for symptomatic relief or as directed.

Special Instructions:

• Avoid application to broken or infected skin unless advised.
• Do not apply near open flames due to flammability.

Light Liquid Paraffin and White Soft Paraffin are occlusive emollients that form a semi-occlusive film on the skin surface, preventing transepidermal water loss and improving skin hydration. Glycerine (glycerol) is a hygroscopic humectant that draws water from the deeper skin layers and the external environment into the stratum corneum. This combination restores skin barrier function, soothes irritation, and alleviates symptoms such as dryness, itching, and scaling in various dermatological conditions.

Absorption:

• Minimal systemic absorption with topical use.
• Glycerine may be slightly absorbed into the epidermis.

Distribution:

• Not systemically distributed.

Metabolism:

• Not significantly metabolized due to minimal absorption.

Excretion:

• Not applicable; acts locally.

Onset of Action:

• Relief often begins within minutes of application.

Bioavailability:

• Not applicable (topical use only).

Half-life:

• Not applicable.

• Pregnancy: Considered safe for external use. No evidence of teratogenicity or fetal harm.
• Lactation: Safe for use during breastfeeding. Avoid application to the nipple area prior to nursing.
• Caution: Avoid excessive or prolonged use on large areas of the skin.

• Primary Class: Emollient and Skin Protectant
• Subclass: Occlusive and Humectant Moisturizer

• Known hypersensitivity to any component (Light Liquid Paraffin, White Soft Paraffin, Glycerine)
• Application on infected or broken skin without medical supervision
• Use in or near the eyes

• Flammability Warning:
• Paraffin-based products are flammable. Keep away from fire and naked flames.
• Clothing and bedding in contact with the product may retain fire risk, even after washing.
• Skin Reactions:
• Discontinue use if irritation, rash, or allergic reaction occurs.
• Occlusion Risk:
• Overuse under occlusive dressings may cause folliculitis or maceration.
• Avoid Contact with Eyes:
• Rinse thoroughly with water if accidental eye contact occurs.
• Do Not Use on Infected Areas:
• Unless prescribed with appropriate antimicrobial agents.

Common (Mild):

• Local skin irritation
• Greasy or sticky feeling on skin
• Transient burning or stinging sensation

Less Common:

• Contact dermatitis or allergic skin reaction
• Folliculitis (especially under occlusion)

Rare (Severe):

• Secondary bacterial infection (if used on infected skin)
• Flare-up of pre-existing dermatitis

• Drug-Drug Interactions: Not systemically absorbed; interactions are clinically insignificant.
• Topical Interactions: Avoid use with other occlusive or potentially irritating topical agents unless advised by a healthcare provider.
• Enzyme Involvement: None; not metabolized via CYP450 or other systemic enzyme pathways.

• Regulatory Updates:
• Authorities (e.g., MHRA, EMA) have emphasized updated labeling for paraffin-based products to include flammability warnings.
• Patient education campaigns have been initiated to reduce fire hazards associated with paraffin products.
• Clinical Practice Trends:
• Emollient combinations with humectants like glycerine are now preferred for long-term management of chronic dermatoses, particularly in children and elderly populations.

• Temperature: Store below 25°C.
• Humidity: Keep in a dry environment.
• Light: Protect from direct sunlight.
• Container: Keep tightly closed when not in use.
• Special Instructions:
• Do not freeze.
• Keep away from naked flames or heat sources.
• Avoid contamination by not inserting fingers directly into containers.