Light liquid paraffin

Approved Indications:

• Oral Use (Laxative):
• Short-term relief of constipation, especially in elderly, post-operative, or non-ambulatory patients.
• Management of fecal impaction in certain cases (under medical supervision).
• Topical Use (Dermatological):
• Dry skin conditions including eczema, psoriasis, ichthyosis, and xerosis.
• Pruritus, especially in elderly individuals with aging or flaky skin.
• Cradle cap and nappy rash in infants.
• Soothing and moisturizing treatment for minor burns, radiation dermatitis, and skin irritation.

Clinically Accepted Off-Label Uses:

• Adjunct in managing anal fissures (to reduce trauma during defecation).
• Supportive skin care in patients undergoing chemotherapy or dialysis, where skin dryness is prevalent.

Route of Administration:

• Oral (as laxative)
• Topical (as emollient)

Oral Use

Adults:

• 15–30 mL once daily, preferably at bedtime.

Children over 3 years:

• 5–15 mL once daily, at bedtime (only under medical advice).

Elderly:

• Use with caution. Start at the lowest effective dose to minimize aspiration risk.

Duration:

• Limit use to no more than 7 consecutive days to avoid complications such as lipid pneumonia or vitamin malabsorption.

Administration Notes:

• Take on an empty stomach.
• Avoid taking with meals or before lying down.
• Shake the bottle well before each use.

Topical Use

Adults and Children:

• Apply a thin layer to the affected area 2–3 times daily or as needed.
• Massage gently into the skin until absorbed.

Infants:

• Safe for use on nappy rash and cradle cap. Apply sparingly.

• Topical: Light Liquid Paraffin forms an occlusive barrier over the skin, reducing trans-epidermal water loss. This helps retain skin moisture, softens the stratum corneum, and restores the natural lipid barrier, relieving dryness and irritation.
• Oral: Acts as a lubricant laxative by coating the bowel lining and stool surface, reducing water absorption from the stool and facilitating its passage. It does not stimulate bowel motility.

Topical Use:

• Absorption: Negligible through intact skin.
• Onset: Immediate moisturizing effect upon application.
• Systemic exposure: Minimal to none.

Oral Use:

• Absorption: Poorly absorbed from the gastrointestinal tract.
• Distribution: Minimal systemic distribution.
• Metabolism: Not metabolized.
• Excretion: Eliminated unchanged in feces.
• Onset of Action: Typically 6 to 8 hours after ingestion.
• Bioavailability: Not systemically bioavailable.

Pregnancy:

• Topical use: Safe throughout all trimesters.
• Oral use: Not recommended, especially in the third trimester, due to the risk of maternal aspiration and impaired absorption of fat-soluble vitamins.

Lactation:

• Topical use: Considered safe during breastfeeding.
• Oral use: Use with caution; may cause loose stools in breastfed infants if absorbed in significant amounts.

Recommendation:
Topical application is safe in both pregnancy and lactation. Oral use should be avoided unless absolutely necessary and supervised by a physician.

• Primary Class:
• Topical Emollient and Skin Protectant
• Oral Lubricant Laxative
• Subclass:
• Mineral oil derivative
• Non-stimulant laxative

• Hypersensitivity to paraffin or any excipients.
• Intestinal obstruction, appendicitis, or undiagnosed abdominal pain (oral use).
• Dysphagia or aspiration risk (oral use).
• Rectal bleeding or lack of bowel movement after use (oral use).
• Use in infants under 3 years (oral use).

• Aspiration Risk (oral): May cause lipoid pneumonia, especially in elderly, debilitated, or sedated patients.
• Nutrient Malabsorption: Long-term use may impair absorption of fat-soluble vitamins (A, D, E, K).
• Anal seepage: May occur due to leakage of paraffin oil.
• Fire Hazard (topical): Highly flammable—avoid smoking or open flames after application and around treated fabrics.
• Folliculitis or acne-like eruptions can occur with overuse, especially in oily skin.
• Use cautiously in children and elderly patients.

Topical Use:

• Common:
• Mild skin irritation
• Greasiness
• Uncommon:
• Contact dermatitis
• Folliculitis
• Rare:
• Acneiform eruptions
• Allergic reactions

Oral Use:

• Common:
• Diarrhea
• Anal leakage or discomfort
• Rare:
• Lipoid pneumonia (aspiration)
• Fat-soluble vitamin deficiency (with prolonged use)

Timing & Severity:
Topical side effects are generally mild and local. Oral adverse effects are more severe when misused or used long-term.

Oral Use:

• May impair absorption of:
• Fat-soluble vitamins (A, D, E, K)
• Oral contraceptives
• Anticoagulants (e.g., warfarin)
• Avoid co-administration with bulk-forming laxatives or other stool softeners.

Topical Use:

• No known significant drug interactions.
• May affect percutaneous absorption of concurrently applied topical drugs.

CYP450 involvement: Not applicable due to negligible systemic absorption.

• MHRA and NHS have issued fire safety warnings due to paraffin build-up in clothing and bedding, emphasizing the need to avoid open flames and washing fabrics regularly.
• Recent dermatology guidelines continue to recommend paraffin-based emollients as first-line for eczema and other dry skin disorders.
• Clinical use of oral paraffin is increasingly restricted to short-term use only, due to aspiration risk.

• Store between 15°C to 25°C (59°F to 77°F)
• Protect from direct sunlight
• Do not freeze
• Keep tightly closed and in original container
• Keep away from fire or open flames
• For topical products, clean nozzle and cap after each use
• Keep out of reach of children