Mineral oil

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.

Pharmacology
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Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
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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
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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.
DrugInteraction
AcetazolamideThe risk or severity of adverse effects can be increased when Acetazolamide is combined with Mineral oil.
AclidiniumThe therapeutic efficacy of Mineral oil can be decreased when used in combination with Aclidinium.
AlfacalcidolMineral oil can cause a decrease in the absorption of Alfacalcidol resulting in a reduced serum concentration and potentially a decrease in efficacy.
AlfentanilThe therapeutic efficacy of Mineral oil can be decreased when used in combination with Alfentanil.
AlloinThe risk or severity of adverse effects can be increased when Mineral oil is combined with Alloin.
AmantadineThe therapeutic efficacy of Mineral oil can be decreased when used in combination with Amantadine.
AmilorideThe risk or severity of adverse effects can be increased when Amiloride is combined with Mineral oil.
AmiodaroneThe therapeutic efficacy of Mineral oil can be decreased when used in combination with Amiodarone.
AmitriptylineThe therapeutic efficacy of Mineral oil can be decreased when used in combination with Amitriptyline.
AmlodipineThe therapeutic efficacy of Mineral oil can be decreased when used in combination with Amlodipine.
Interactions
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Food Interactions
No interactions found.

Products

Products
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Over the Counter Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
4718 Enema, Mineral OilEnema100 g/118gRectalDynarex2021-02-26Not applicableUS flag
Amoray Care BabyOil99.9 g/100mLTopicalMy Import Inc2015-03-262017-02-10US flag
Bath Oil Liq 63.4%Liquid63.4 %TopicalBebia Pediatric, Division Of Stiefel Canada Inc.1991-12-311996-09-09Canada flag
Camellia Cleansing BalmSalve54.0999 g/100mLTopicalTov Co., Ltd2016-11-07Not applicableUS flag
Canadian National Pharma Group Inc Mineral Oil Heavy USPLiquid100 %OralCanadian National Pharma Group IncNot applicableNot applicableCanada flag
Clean It Zero RadianceCream63.2 mg/100mLTopicalF&Co Co., Ltd.2014-07-012019-11-01US flag
Conju Princess Cleansing BalmGel72.27 g/100mLTopicalConju Korea Inc.2019-03-01Not applicableUS flag
CURAD Lubricant LaxativeEnema118 mL/118mLRectalMedline Industries2012-07-162015-01-01US flag
CVS Mineral OilLiquid1000 mg/1mLOralCVS2020-01-31Not applicableUS flag
Dynarex LaxativeLiquid99 g/100gOralDynarex Corporation2014-03-05Not applicableUS flag
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
7 Select Hemorrhoidal Original StrengthMineral oil (140 mg/1g) + Petrolatum (749 mg/1g) + Phenylephrine hydrochloride (2.5 mg/1g)OintmentTopical7-ELEVEN, INC.2016-12-07Not applicableUS flag
AGAROLMineral oil (28.22 mg) + Sodium picosulfate monohydrate (33.34 mg)EmulsionOralCOASPHARMA S.A.S.2018-06-22Not applicableColombia flag
Agarol Eml StrawberryMineral oil (1.6 mL / 5 mL) + Glycerin (200 mg / 5 mL) + Phenolphthalein (65 mg / 5 mL)EmulsionOralWarner Lambert Canada Inc.1992-12-311997-09-15Canada flag
Agarol PlainMineral oil (1.6 mL / 5 mL) + Glycerin (800 mg / 5 mL)EmulsionOralNumark Laboratories, Inc.1998-11-302016-06-02Canada flag
Agarol Plain EmlMineral oil (1.6 mL / 5 mL) + Glycerin (800 mg / 5 mL)EmulsionOralWarner Lambert Canada Inc.1992-12-311998-08-17Canada flag
Agarol Vanilla Laxative LiqMineral oil (1.6 mL / 5 mL) + Glycerin (200 mg / 5 mL) + Phenolphthalein (65 mg / 5 mL)LiquidOralWarner Lambert Canada Inc.1992-12-311997-09-15Canada flag
Alpha KeriMineral oil (91.7 %) + Lanolin (3 %)LiquidTopicalBristol Myers Squibb1958-12-311999-08-09Canada flag
AltalubeMineral oil (150 mg/1g) + Petrolatum (850 mg/1g)OintmentOphthalmicAltaire Pharmaceuticals Inc.2002-02-01Not applicableUS flag
Apj HemorrhoidalMineral oil (140 mg/1g) + Petrolatum (720 mg/1g) + Phenylephrine hydrochloride (2.55 mg/1g)OintmentTopicalA P J Laboratories Limited2013-07-01Not applicableUS flag
Artificial EyeMineral oil (150 mg/1g) + Petrolatum (830 mg/1g)OintmentOphthalmicDelsam Pharma Llc2020-08-11Not applicableUS flag
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Camellia Cleansing BalmMineral oil (54.0999 g/100mL)SalveTopicalTov Co., Ltd2016-11-07Not applicableUS flag
FleetMineral oil (100 g/100mL) + Witch hazel (5 g/1)KitRectal; TopicalC.B. Fleet Company, Inc.2019-02-15Not applicableUS flag
IonicMineral oil (100 g/100mL)LiquidTopicalAML Bio Co., Ltd.2020-11-09Not applicableUS flag
Keeper medalMineral oil (100 g/100mL)LiquidTopicalAML Bio Co., Ltd.2020-11-09Not applicableUS flag
Mizon Collagenic Aqua Volume Up Li P Essence RenewalMineral oil (7.26 g/10mL) + Octinoxate (0.40 g/10mL)LiquidTopicalMizon Co.,Ltd.2018-07-01Not applicableUS flag
Nature and Health Beauty (Moisturizing Cream, Whitening Cream)Mineral oil (1.2 g/120g) + Glycerin (1.2 g/120g)CreamTopicalNature And Health Beauty Co., Ltd.2015-04-16Not applicableUS flag
Nature and Health Beauty (Moisturizing Cream, Whitening Cream) (Mineral Oil and Glycerin)Mineral oil (1.2 g/120g) + Glycerin (1.2 g/120g)CreamTopicalNature And Health Beauty Co., Ltd.2016-03-13Not applicableUS flag
Nature and Health Beauty (Moisturizing Cream, Whitening Cream) (Mineral Oil and Glycerin)Mineral oil (1 g/100mL) + Glycerin (1 g/100mL)CreamTopicalNature And Health Beauty Co., Ltd.2016-03-23Not applicableUS flag
Pyung Gang Ato SoonMineral oil (0.45 g/45g)CreamTopicalPyung Gang Oriental Medical Clinic2015-04-02Not applicableUS flag
Pyung Gang Ato SoonMineral oil (0.45 g/45mL)CreamTopicalPyung Gang Oriental Medical Clinic2015-04-02Not applicableUS flag

Categories

ATC Codes
A06AA01 — Liquid paraffinA06AA51 — Liquid paraffin, combinations
Drug Categories
Classification
Not classified
Affected organisms
Not Available

Chemical Identifiers

UNII
T5L8T28FGP
CAS number
8042-47-5

References

General References
  1. 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]
  2. Kleiman N (2018). Dry Skin. In Compendium of Therapeutic Choices for Minor Ailments (2nd ed.). Canadian Pharmacists Association.
PubChem Substance
347911096
RxNav
258439
Wikipedia
Mineral_oil
AHFS Codes
  • 84:24.12 — Basic Ointments and Protectants
  • 56:12.00 — Cathartics and Laxatives
MSDS
Download (48 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedBasic ScienceInflammation1
4CompletedDiagnosticAnatomic renal artery stenosis / Chronic Kidney Disease (CKD) / Pulmonary Cancer / Pulmonary Embolism1
4CompletedDiagnosticCoronary Artery Stenosis1
4CompletedOtherHepato Cellular Carcinoma1
4CompletedTreatmentDry Eye Syndrome (DES)1
4CompletedTreatmentDry Eye Syndromes1
4Not Yet RecruitingSupportive CareThe Study Focus to Improve the Standard of Care Used for Aluminuim Phosphide Poisoning and to Save Patients With the Minimal Organ Damage1
4Unknown StatusTreatmentDermatitis, Contact / Dermatitis, Occupational1
4Unknown StatusTreatmentFemale Infertility1
4WithdrawnTreatmentIron Deficiency (ID)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
EnemaRectal100 g/118g
SolutionOral100 mL
EmulsionOral
SuspensionOral
LiquidOral
OilTopical99.9 g/100mL
SuspensionTopical
LiquidTopical63.4 %
StickTopical
SalveTopical54.0999 g/100mL
CreamTopical63.2 mg/100mL
GelTopical72.27 g/100mL
OintmentOphthalmic
LiquidOral99 g/100g
EnemaRectal1 mL/1mL
EnemaRectal118 mL/118mL
LiquidRectal100 mL/100mL
LiquidRectal100 g/100mL
KitOphthalmic
OintmentTopical52.74 % w/w
LotionTopical18 %
EnemaRectal100 g/100mL
KitRectal; Topical
EnemaRectal100 %
OintmentTopical100 %
GelTopical
LotionTopical100 %
CreamRectal
LiquidOral
SolutionTopical
LiquidOral; Topical
LiquidOral1000 mg/1mL
LiquidTopical1000 mg/1mL
LiquidTopical8 g/100mL
GelOral78 % w/w
LiquidTopical100 g/100mL
LiquidOral2.12 g/5mL
LiquidOral2.5 mL/5mL
GelOral78 %
LiquidTopical
LiquidTopical100 %
OintmentRectal; Topical
EnemaRectal113.115 g/118mL
EnemaRectal118 g/118mL
LiquidOral100 %
LiquidOral999 mg/1mL
LiquidOral; Topical99.9 mg/1mL
LiquidOral; Topical999 mg/1mL
OilOral100 mg/100mL
OilOral471.9528 g/472mL
OilOral; Topical100 mg/100mL
OilOral; Topical15 mg/15mL
OilOral; Topical15 mL/15mL
OilOral; Topical15 mg/15mg
OilRectal100 g/100g
SolutionOral1000 mg/1mL
OilTopical471.99 g/472mL
LiquidOral30 mL / dose
SolutionOral99.9 % w/w
SolutionOral99.9 %
CreamTopical
OilTopical
LiquidTopical
OilTopical327.54 g/410mL
OilOral1 mg/1mL
OilTopical99.9 mL/100mL
EmulsionOral
OilOral999 mg/1mL
CreamTopical0.45 g/45g
CreamTopical0.45 g/45mL
EmulsionOphthalmic
LinimentTopical
LiquidTopical75 mg/150mL
OilTopical99.5 g/100mL
OintmentTopical
CreamTopical49.46 g/90mL
OilTopical100 mL/100mL
OilTopical1 mL/1mL
Solution / dropsOphthalmic
GelOphthalmic
LotionTopical
OintmentRectal
OilTopical100 g/200mL
Suspension
EmulsionOral4.83 ml/15ML
EmulsionOral7.5 mg/15ML
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
PropertyValueSource
boiling point (°C)310MSDS
water solubilityInsolubleMSDS
Predicted Properties
Not Available
Predicted ADMET Features
Not Available

Spectra

Mass Spec (NIST)
Not Available
Spectra
Not Available

Drug created on December 03, 2015 16:51 / Updated on June 13, 2021 16:25