MedPath

Mineral oil

Generic Name
Mineral oil
Brand Names
Fleet Mineral Oil, Lubrifresh P.M., Meijer, Preparation H Reformulated Jun 2013, Refresh Lacri-lube, Refresh PM, Retaine Mgd, Soothe Mineral Oil, Soothe Night Time, Stye, Systane, Systane Nighttime, Tears Again Ointment
Drug Type
Small Molecule
CAS Number
8042-47-5
Unique Ingredient Identifier
T5L8T28FGP

Overview

Mineral oil, or paraffin oil, is a mixture of higher alkanes from a mineral source, such as petroleum. Petroleum mineral oil is manufactured from crude oils by vacuum distillation to produce several distillates and a residual oil that are then further refined. During the modern refining process, aromatics are reduced by solvent extraction, catalytic hydrotreating, or hydrocracking. Unrefined or mildly treated mineral oils are classified as Group 3 carcinogens by the World Health Organizations, as chronic exposure to these aromatics including alkylated polycyclic aromatic compounds (PAC) can lead to skin cancer. Mineral oil is a common ingredient in baby lotions, cold creams, ointments and cosmetics to treat and prevent dry, rough, scaly, itchy skin and minor skin irritations. It is also used as a mild laxative for human or veterinary uses.

Background

Mineral oil, or paraffin oil, is a mixture of higher alkanes from a mineral source, such as petroleum. Petroleum mineral oil is manufactured from crude oils by vacuum distillation to produce several distillates and a residual oil that are then further refined. During the modern refining process, aromatics are reduced by solvent extraction, catalytic hydrotreating, or hydrocracking. Unrefined or mildly treated mineral oils are classified as Group 3 carcinogens by the World Health Organizations, as chronic exposure to these aromatics including alkylated polycyclic aromatic compounds (PAC) can lead to skin cancer. Mineral oil is a common ingredient in baby lotions, cold creams, ointments and cosmetics to treat and prevent dry, rough, scaly, itchy skin and minor skin irritations. It is also used as a mild laxative for human or veterinary uses.

Indication

Mineral oil is not considered an active pharmacological ingredient in pharmaceutical preparations and so has no official indication. It is typically present in topical formulations as an emollient and occlusive agent .

Associated Conditions

  • Constipation

FDA Approved Products

Mineral Oil
Manufacturer:Perrigo Direct, Inc.
Route:ORAL, TOPICAL
Strength:999 mg in 1 mL
Approved: 2025/03/31
NDC:50804-831
Mineral oil
Manufacturer:CVS Pharmacy
Route:ORAL
Strength:999 mg in 1 mL
Approved: 2025/03/24
NDC:51316-831
HemorrhoidalOintment
Manufacturer:Trifecta Pharmaceuticals USA LLC
Route:TOPICAL
Strength:14 g in 100 g
Approved: 2025/02/07
NDC:69396-020
Mineral Oil
Manufacturer:TOP CARE (Topco Associates LLC)
Route:ORAL, TOPICAL
Strength:100 mg in 100 mL
Approved: 2025/04/09
NDC:36800-334
hemorrhoidal
Manufacturer:Bionpharma Inc.
Route:TOPICAL
Strength:140 mg in 1 g
Approved: 2025/03/31
NDC:69452-448

Singapore Approved Products

LIQUID PARAFFIN EMULSION 2.5 ml/5 ml
Manufacturer:BEACONS PHARMACEUTICALS PTE. LTD.
Form:EMULSION
Strength:2.5 ml/5 ml
Online:Yes
Approved: 1994/02/22
Approval:SIN07649P
LAXAROL ORAL EMULSION 50% v/v
Manufacturer:ICM PHARMA PTE. LTD.
Form:EMULSION
Strength:50% v/v
Online:Yes
Approved: 1996/07/03
Approval:SIN08800P

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