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.

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Used in combination to treatConstipationCombination Product in combination with: Picosulfuric acid (DB09268)••• •••••••••••
Contraindications & Blackbox Warnings
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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 dehydration 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.
Food Interactions
No interactions found.

Products

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Over the Counter Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
4718 Enema, Mineral OilEnema133 g/133mLRectalDynarex2021-02-26Not applicableUS flag
Amoray Care BabyOil99.9 g/100mLTopicalMy Import Inc2015-03-262017-02-10US flag
Aquaphor Healing OintmentOintment52.74 % w/wTopicalBeiersdorf2020-09-18Not applicableCanada 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
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
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Camellia Cleansing BalmMineral oil (54.0999 g/100mL)SalveTopicalTov Co., Ltd2016-11-07Not applicableUS flag
Elgoalin HISENGMineral oil (55 g/100g) + Petrolatum (35 g/100g)LiquidTopicalElgoalin Bio Co.,Ltd2022-04-18Not applicableUS flag
FleetMineral oil (100 g/100mL) + Witch hazel (5 g/1)KitRectal; TopicalC.B. Fleet Company, Inc.2019-02-15Not applicableUS flag
HANHOO BlemishPatchMineral oil (4.25 g/100g)PatchTopicalNew Bio Pharmaceutical Co., Ltd.2023-12-07Not applicableUS flag
iBOMineral oil (55 g/100mL)LiquidOralElgoalin Bio Co.,Ltd2022-04-18Not 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
MSDS
Download (48 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedBasic ScienceInflammation1
4CompletedDiagnosticAnatomic renal artery stenosis / Chronic Kidney Disease (CKD) / Lung Cancer / Pulmonary Embolism1
4CompletedDiagnosticCoronary Artery Stenosis1
4CompletedOtherHepatocellular Carcinoma1
4CompletedTreatmentDry Eye Syndrome (DES)2

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
EnemaRectal133 g/133mL
SolutionOral100 mL
SuspensionOral
LiquidOral
OilTopical99.9 g/100mL
OintmentTopical52.74 % w/w
SuspensionTopical
LiquidTopical63.4 %
StickTopical
SalveTopical54.0999 g/100mL
CreamTopical63.2 mg/100mL
GelTopical72.27 g/100mL
SprayTopical59.8 g/100g
OintmentOphthalmic
LiquidOral99 g/100g
EnemaRectal1 mL/1mL
EnemaRectal118 mL/118mL
LiquidRectal100 mL/100mL
LiquidRectal100 g/100mL
KitOphthalmic
SolutionOphthalmic
LotionTopical18 %
EnemaRectal100 g/100mL
KitRectal; Topical
EnemaRectal100 %
EnemaRectal100 % w/w
OintmentTopical100 %
GelTopical
PatchTopical4.25 g/100g
LotionTopical100 %
CreamRectal
LiquidOral
SolutionTopical
LiquidOral; Topical
LiquidOral1000 mg/1mL
LiquidTopical1000 mg/1mL
LiquidOral55 g/100mL
LiquidTopical8 g/100mL
GelOral78 % w/w
LiquidTopical100 g/100mL
LiquidOral2.12 g/5mL
LiquidOral2.5 mL/5mL
GelOral78 %
EmulsionOral50 % v/v
LiquidTopical
EmulsionOral2.5 ml/5ml
EmulsionOral
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 mg/15mg
OilOral; Topical15 mL/15mL
OilRectal100 g/100g
SolutionOral1000 mg/1mL
LiquidTopical100 %
OilTopical471.99 g/472mL
LiquidOral30 mL / dose
SolutionOral99.9 %
SolutionOral99.9 % w/w
CreamTopical
OilTopical
LiquidTopical
OilTopical327.54 g/410mL
OilOral1 mg/1mL
OilTopical99.9 mL/100mL
EmulsionOral
OilOral999 mg/1mL
OintmentTopical14 %
CreamTopical0.45 g/45mL
CreamTopical0.45 g/45g
Cloth; cream; kitTopical
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
GelOral35.0000 g
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
Chromatographic Properties
Collision Cross Sections (CCS)
Not Available

Drug created at December 03, 2015 16:51 / Updated at March 28, 2024 03:23