Mineral oil

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.

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

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Evaluate the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty	2020/10/14	NCT04585230	Not Applicable	UNKNOWN	Rothman Institute Orthopaedics
A New Scoring System Improves Diagnostic Accuracy of Intestinal Dysganglionosis --a Prospective Study	2014/08/15	NCT02216994	Not Applicable	UNKNOWN	Tongji Hospital
Reducing Urethral Pain During Urodynamic Test - Comparison Between Lidocaine Gel and Paraffin Oil	2013/04/23	NCT01837628	Not Applicable	UNKNOWN	Assaf-Harofeh Medical Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Mineral Oil	ATLANTIC BIOLOGICALS CORP.	17856-1110	ORAL	999 mg in 1 mL	5/23/2025
Mineral Oil	TOP CARE (Topco Associates LLC)	36800-334	ORAL, TOPICAL	100 mg in 100 mL	4/9/2025
Mineral oil	CVS Pharmacy	51316-831	ORAL	999 mg in 1 mL	3/24/2025
HemorrhoidalOintment	Trifecta Pharmaceuticals USA LLC	69396-020	TOPICAL	14 g in 100 g	2/7/2025
Mineral Oil	Perrigo Direct, Inc.	50804-831	ORAL, TOPICAL	999 mg in 1 mL	3/31/2025
Harris Teeter	Harris Teeter	69256-831	ORAL	999 mg in 1 mL	5/1/2025
Hemorrhoidal Pain Relief	Neilmed Pharmaceuticals Inc.	13709-334	TOPICAL	140 mg in 1 g	6/11/2025
hemorrhoidal	Bionpharma Inc.	69452-448	TOPICAL	140 mg in 1 g	3/31/2025

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
LIQUID PARAFFIN EMULSION 2.5 ml/5 ml	BEACONS PHARMACEUTICALS PTE. LTD.	SIN07649P	EMULSION	2.5 ml/5 ml	2/22/1994
LAXAROL ORAL EMULSION 50% v/v	ICM PHARMA PTE. LTD.	SIN08800P	EMULSION	50% v/v	7/3/1996

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
KUGELMANS HERBAL HEAT LINIMENT bottle	45809	H.E Kugelman & Co	Medicine	A	7/21/1993
AGAROL liquid paraffin 322mL/L oral liquid bottle	62657	Johnson & Johnson Pacific Pty Ltd	Medicine	A	12/23/1997
Gold Cross Liquid Paraffin	27637	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	11/11/1991
ALPHA KERI BATH & BODY OIL application bottle	24618	Mentholatum Australasia Pty Ltd	Medicine	A	10/14/1991
EGO EMOLLIENT BATH OIL solution bottle	10628	Ego Pharmaceuticals Pty Ltd	Medicine	A	8/2/1991
MICROLAX ORAL LIQUID liquid paraffin 4.83mL/15mL bottle	291431	Johnson & Johnson Pacific Pty Ltd	Medicine	A	7/12/2017
ALPHA KERI Lotion bottle	24617	Mentholatum Australasia Pty Ltd	Medicine	A	10/14/1991
LITTLE PARACHOC liquid paraffin 0.5 mL/mL oral liquid bottle	20865	Care Pharmaceuticals Pty Ltd	Medicine	A	10/15/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
LAXAROL	therapex division de e-z-em canada inc	00628778	Liquid - Oral	1.6 ML / 5 ML	12/31/1985
FORMULATION R HEMORRHOIDAL OINTMENT	g&w laboratories inc.	02246389	Ointment - Topical	14 %	N/A
HEAVY MINERAL OIL	d.c. labs limited	00093947	Liquid - Oral	null NIL / NIL	12/31/1974
MILK OF MAGNESIA MINERAL OIL EMULSION	bdh inc.	02142996	Emulsion - Oral	20 % / 30 ML	12/31/1995
TEARS NATURALE P.M.	Alcon Canada Inc	02082519	Ointment - Ophthalmic	3 %	10/7/1998
SEBAMED DIAPER RASH CREAM	lofco canada inc.	02240541	Cream - Topical	7.00 %	4/17/2000
MINERAL OIL USP	bdh inc.	02142961	Liquid - Oral	30 ML / DOSE	12/31/1995
KERI LOTION	bristol-myers squibb canada	02126117	Lotion - Topical	15.9 %	12/31/1962
HUILE MINERALE	rougier pharma division of ratiopharm inc	00481386	Liquid - Oral	100 %	12/31/1980
HUILE MINERALE	j l mathieu cie ltee	00460745	Liquid - Oral	100 %	12/31/1979

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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