Identification
- 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
- Generic Name
- Mineral oil
- DrugBank Accession Number
- DB11057
- 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.
- Type
- Small Molecule
- Groups
- Approved, Vet approved
- Synonyms
- Food Grade Mineral Oil
- Heavy Liquid Petrolatum
- Heavy mineral oil
- Liquid Paraffin
- Liquid Petrolatum
- Mineral oil
- Mineral Oil (high Viscosity)
- Mineral Oil, Heavy
- Paraffin Oil
- Paraffin, Liquid
- Paraffinum Liquidum
- Petrolatum, Liquid
- White Mineral Oil
- External IDs
- 232-455-8
- E-905D
- INS No.905D
- INS-905D
Pharmacology
- 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 2.
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- Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.- Pharmacodynamics
Mineral oil blocks the loss of water from the skin allowing greater hydration of the epidermis 2.
- Mechanism of action
Mineral oil sits on the surface of the skin and in spaces between cells and provides a hydrophobic barrier 2. This barrier prevents trans-epidermal water loss to trap water in the skin. Overall this leads to greater hydration, flexibility, and softness of the stratum corneum.
- Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
Not Available
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
Not Available
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAcetazolamide The risk or severity of dehydration can be increased when Acetazolamide is combined with Mineral oil. Aclidinium The therapeutic efficacy of Mineral oil can be decreased when used in combination with Aclidinium. Alfacalcidol Mineral oil can cause a decrease in the absorption of Alfacalcidol resulting in a reduced serum concentration and potentially a decrease in efficacy. Alfentanil The therapeutic efficacy of Mineral oil can be decreased when used in combination with Alfentanil. Alloin The risk or severity of adverse effects can be increased when Mineral oil is combined with Alloin. Amantadine The therapeutic efficacy of Mineral oil can be decreased when used in combination with Amantadine. Amiloride The risk or severity of dehydration can be increased when Amiloride is combined with Mineral oil. Amiodarone The therapeutic efficacy of Mineral oil can be decreased when used in combination with Amiodarone. Amitriptyline The therapeutic efficacy of Mineral oil can be decreased when used in combination with Amitriptyline. Amlodipine The therapeutic efficacy of Mineral oil can be decreased when used in combination with Amlodipine. 
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- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Over the Counter Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image 4718 Enema, Mineral Oil Enema 133 g/133mL Rectal Dynarex 2021-02-26 Not applicable US 
Amoray Care Baby Oil 99.9 g/100mL Topical My Import Inc 2015-03-26 2017-02-10 US Bath Oil Liq 63.4% Liquid 63.4 % Topical Bebia Pediatric, Division Of Stiefel Canada Inc. 1991-12-31 1996-09-09 Canada 
Camellia Cleansing Balm Salve 54.0999 g/100mL Topical Tov Co., Ltd 2016-11-07 Not applicable US Canadian National Pharma Group Inc Mineral Oil Heavy USP Liquid 100 % Oral Canadian National Pharma Group Inc Not applicable Not applicable Canada Clean It Zero Radiance Cream 63.2 mg/100mL Topical F&Co Co., Ltd. 2014-07-01 2019-11-01 US Conju Princess Cleansing Balm Gel 72.27 g/100mL Topical Conju Korea Inc. 2019-03-01 Not applicable US CURAD Lubricant Laxative Enema 118 mL/118mL Rectal Medline Industries 2012-07-16 2015-01-01 US CVS Mineral Oil Liquid 1000 mg/1mL Oral CVS 2020-01-31 Not applicable US Dr. Butler Hemorrhoid and Perineal Spray 59.8 g/100g Topical Beyond Health p.a. 2021-07-26 Not applicable US - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image 7 Select Hemorrhoidal Original Strength Mineral oil (140 mg/1g) + Petrolatum (749 mg/1g) + Phenylephrine hydrochloride (2.5 mg/1g) Ointment Topical 7-ELEVEN, INC. 2016-12-07 Not applicable US AGAROL Mineral oil (28.22 mg) + Sodium picosulfate monohydrate (33.34 mg) Emulsion Oral COASPHARMA S.A.S. 2018-06-22 Not applicable Colombia 
Agarol Eml Strawberry Mineral oil (1.6 mL / 5 mL) + Glycerin (200 mg / 5 mL) + Phenolphthalein (65 mg / 5 mL) Emulsion Oral Warner Lambert Canada Inc. 1992-12-31 1997-09-15 Canada Agarol Plain Mineral oil (1.6 mL / 5 mL) + Glycerin (800 mg / 5 mL) Emulsion Oral Numark Laboratories, Inc. 1998-11-30 2016-06-02 Canada Agarol Plain Eml Mineral oil (1.6 mL / 5 mL) + Glycerin (800 mg / 5 mL) Emulsion Oral Warner Lambert Canada Inc. 1992-12-31 1998-08-17 Canada Agarol Vanilla Laxative Liq Mineral oil (1.6 mL / 5 mL) + Glycerin (200 mg / 5 mL) + Phenolphthalein (65 mg / 5 mL) Liquid Oral Warner Lambert Canada Inc. 1992-12-31 1997-09-15 Canada Alpha Keri Mineral oil (91.7 %) + Lanolin (3 %) Liquid Topical Bristol Myers Squibb 1958-12-31 1999-08-09 Canada Altalube Mineral oil (150 mg/1g) + Petrolatum (850 mg/1g) Ointment Ophthalmic Altaire Pharmaceuticals Inc. 2002-02-01 Not applicable US Apj Hemorrhoidal Mineral oil (140 mg/1g) + Petrolatum (720 mg/1g) + Phenylephrine hydrochloride (2.55 mg/1g) Ointment Topical A P J Laboratories Limited 2013-07-01 Not applicable US Aquax Mineral oil (75 mg/150g) + Petrolatum (75 mg/150g) Cream Topical Pella Pharmaceuticals Co. ltd 2010-03-25 Not applicable US - Unapproved/Other Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Camellia Cleansing Balm Mineral oil (54.0999 g/100mL) Salve Topical Tov Co., Ltd 2016-11-07 Not applicable US Elgoalin HISENG Mineral oil (55 g/100g) + Petrolatum (35 g/100g) Liquid Topical Elgoalin Bio Co.,Ltd 2022-04-18 Not applicable US Fleet Mineral oil (100 g/100mL) + Witch hazel (5 g/1) Kit Rectal; Topical C.B. Fleet Company, Inc. 2019-02-15 Not applicable US iBO Mineral oil (55 g/100mL) Liquid Oral Elgoalin Bio Co.,Ltd 2022-04-18 Not applicable US Ionic Mineral oil (100 g/100mL) Liquid Topical AML Bio Co., Ltd. 2020-11-09 Not applicable US Keeper medal Mineral oil (100 g/100mL) Liquid Topical AML Bio Co., Ltd. 2020-11-09 Not applicable US Mizon Collagenic Aqua Volume Up Li P Essence Renewal Mineral oil (7.26 g/10mL) + Octinoxate (0.40 g/10mL) Liquid Topical Mizon Co.,Ltd. 2018-07-01 Not applicable US Nature and Health Beauty (Moisturizing Cream, Whitening Cream) Mineral oil (1.2 g/120g) + Glycerin (1.2 g/120g) Cream Topical Nature And Health Beauty Co., Ltd. 2015-04-16 Not applicable US Nature and Health Beauty (Moisturizing Cream, Whitening Cream) (Mineral Oil and Glycerin) Mineral oil (1 g/100mL) + Glycerin (1 g/100mL) Cream Topical Nature And Health Beauty Co., Ltd. 2016-03-23 Not applicable US Nature and Health Beauty (Moisturizing Cream, Whitening Cream) (Mineral Oil and Glycerin) Mineral oil (1.2 g/120g) + Glycerin (1.2 g/120g) Cream Topical Nature And Health Beauty Co., Ltd. 2016-03-13 Not applicable US
Categories
- ATC Codes
- A06AA01 — Liquid paraffin
- A06AA — Softeners, emollients
- A06A — DRUGS FOR CONSTIPATION
- A06 — DRUGS FOR CONSTIPATION
- A — ALIMENTARY TRACT AND METABOLISM
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- T5L8T28FGP
- CAS number
- 8042-47-5
References
- General References
- Mackerer CR, Griffis LC, Grabowski Jr JS, Reitman FA: Petroleum mineral oil refining and evaluation of cancer hazard. Appl Occup Environ Hyg. 2003 Nov;18(11):890-901. [Article]
- Kleiman N (2018). Dry Skin. In Compendium of Therapeutic Choices for Minor Ailments (2nd ed.). Canadian Pharmacists Association.
- External Links
- PubChem Substance
- 347911096
- 258439
- Wikipedia
- Mineral_oil
- MSDS
- Download (48 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Basic Science Inflammation 1 4 Completed Diagnostic Anatomic renal artery stenosis / Chronic Kidney Disease (CKD) / Lung Cancer / Pulmonary Embolism 1 4 Completed Diagnostic Coronary Artery Stenosis 1 4 Completed Other Hepatocellular Carcinoma 1 4 Completed Treatment Dry Eye Syndrome (DES) 2 4 Recruiting Treatment Dry Eyes 1 4 Unknown Status Supportive Care The Study Focus to Improve the Standard of Care Used for Aluminuim Phosphide Poisoning and to Save Patients With the Minimal Organ Damage 1 4 Unknown Status Treatment Contact Dermatitis / Dermatitis, Occupational 1 4 Unknown Status Treatment Female Infertility 1 4 Withdrawn Treatment Iron Deficiency (ID) 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Enema Rectal 133 g/133mL Solution Oral 100 mL Suspension Oral Emulsion Oral Liquid Oral Oil Topical 99.9 g/100mL Suspension Topical Liquid Topical 63.4 % Stick Topical Salve Topical 54.0999 g/100mL Cream Topical 63.2 mg/100mL Gel Topical 72.27 g/100mL Spray Topical 59.8 g/100g Ointment Ophthalmic Liquid Oral 99 g/100g Enema Rectal 1 mL/1mL Enema Rectal 118 mL/118mL Liquid Rectal 100 mL/100mL Liquid Rectal 100 g/100mL Kit Ophthalmic Solution Ophthalmic Ointment Topical 52.74 % w/w Lotion Topical 18 % Enema Rectal 100 g/100mL Kit Rectal; Topical Enema Rectal 100 % Enema Rectal 100 % w/w Ointment Topical 100 % Gel Topical Lotion Topical 100 % Cream Rectal Liquid Oral Solution Topical Liquid Oral; Topical Liquid Oral 1000 mg/1mL Liquid Topical 1000 mg/1mL Liquid Oral 55 g/100mL Liquid Topical 8 g/100mL Gel Oral 78 % w/w Liquid Topical 100 g/100mL Liquid Oral 2.12 g/5mL Liquid Oral 2.5 mL/5mL Gel Oral 78 % Emulsion Oral 50 % v/v Liquid Topical Emulsion Oral 2.5 ml/5ml Ointment Rectal; Topical Enema Rectal 113.115 g/118mL Enema Rectal 118 g/118mL Liquid Oral 100 % Liquid Oral 999 mg/1mL Liquid Oral; Topical 99.9 mg/1mL Liquid Oral; Topical 999 mg/1mL Oil Oral 100 mg/100mL Oil Oral 471.9528 g/472mL Oil Oral; Topical 100 mg/100mL Oil Oral; Topical 15 mL/15mL Oil Oral; Topical 15 mg/15mg Oil Oral; Topical 15 mg/15mL Oil Rectal 100 g/100g Solution Oral 1000 mg/1mL Liquid Topical 100 % Oil Topical 471.99 g/472mL Liquid Oral 30 mL / dose Solution Oral 99.9 % Solution Oral 99.9 % w/w Cream Topical Oil Topical Liquid Topical Oil Topical 327.54 g/410mL Oil Oral 1 mg/1mL Oil Topical 99.9 mL/100mL Emulsion Oral Oil Oral 999 mg/1mL Ointment Topical 14 % Cream Topical 0.45 g/45g Cream Topical 0.45 g/45mL Cloth; cream; kit Topical Emulsion Ophthalmic Liniment Topical Liquid Topical 75 mg/150mL Oil Topical 99.5 g/100mL Ointment Topical Cream Topical 49.46 g/90mL Oil Topical 100 mL/100mL Oil Topical 1 mL/1mL Solution / drops Ophthalmic Gel Ophthalmic Lotion Topical Ointment Rectal Gel Oral 35.0000 g Oil Topical 100 g/200mL Suspension Emulsion Oral 4.83 ml/15ML Emulsion Oral 7.5 mg/15ML - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
Property Value Source boiling point (°C) 310 MSDS water solubility Insoluble MSDS - Predicted Properties
- Not Available
- Predicted ADMET Features
- Not Available
Spectra
- Mass Spec (NIST)
- Not Available
- Spectra
- Not Available
Drug created at December 03, 2015 16:51 / Updated at October 02, 2023 21:58