Mineral oil

Identification

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Name
Mineral oil
Accession Number
DB11057
Type
Small Molecule
Groups
Approved, Vet approved
Description

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.

Synonyms
  • Food Grade Mineral Oil
  • Heavy Liquid Petrolatum
  • Heavy mineral oil
  • Liquid Paraffin
  • Liquid Petrolatum
  • 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
Over the Counter Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Amoray Care BabyOil99.9 g/100mLTopicalMy Import Inc2015-03-262017-02-10Us
Bath Oil Liq 63.4%LiquidTopicalBebia Pediatric, Division Of Stiefel Canada Inc.1991-12-311996-09-09Canada
Camellia Cleansing BalmSalve54.0999 g/100mLTopicalTov Co., Ltd2016-11-07Not applicableUs
Canadian National Pharma Group Inc Mineral Oil Heavy USPLiquidOralCanadian National Pharma Group IncNot applicableNot applicableCanada
Clean It Zero RadianceCream63.2 mg/100mLTopicalF&Co Co., Ltd.2014-07-01Not applicableUs
Conju Princess Cleansing BalmGel72.27 g/100mLTopicalConju Korea Inc.2019-03-01Not applicableUs
CURAD Lubricant LaxativeEnema118 mL/118mLRectalMedline Industries2012-07-162015-01-01Us
Dynarex LaxativeLiquid99 g/100gOralDynarex Corporation2014-03-05Not applicableUs
EnemaEnema118 mL/118mLRectalH and P Industries, Inc. dba Triad Group1996-05-22Not applicableUs
EnemaEnema1 mL/1mLRectalDynarex Corporation2012-08-29Not applicableUs
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
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
Agarol Eml StrawberryMineral oil (1.6 ml) + Glycerin (200 mg) + Phenolphthalein (65 mg)EmulsionOralWarner Lambert Canada Inc.1992-12-311997-09-15Canada
Agarol PlainMineral oil (1.6 ml) + Glycerin (800 mg)EmulsionOralNumark Laboratories, Inc.1998-11-302016-06-02Canada
Agarol Plain EmlMineral oil (1.6 ml) + Glycerin (800 mg)EmulsionOralWarner Lambert Canada Inc.1992-12-311998-08-17Canada
Agarol Vanilla Laxative LiqMineral oil (1.6 ml) + Glycerin (200 mg) + Phenolphthalein (65 mg)LiquidOralWarner Lambert Canada Inc.1992-12-311997-09-15Canada
Alpha KeriMineral oil (91.7 %) + Lanolin (3 %)LiquidTopicalBristol Myers Squibb1958-12-311999-08-09Canada
AltalubeMineral oil (150 mg/1g) + Petrolatum (850 mg/1g)OintmentOphthalmicAltaire Pharmaceuticals Inc.2002-02-01Not applicableUs
Apj HemorrhoidalMineral oil (140 mg/1g) + Petrolatum (720 mg/1g) + Phenylephrine hydrochloride (2.55 mg/1g)OintmentTopicalA P J Laboratories Limited2013-07-01Not applicableUs
Artificial TearsMineral oil (150 mg/1g) + Petrolatum (830 mg/1g)OintmentOphthalmicAkorn Animal Health, Inc.2015-06-152015-06-15Us
Artificial TearsMineral oil (150 mg/1g) + Petrolatum (830 mg/1g)OintmentOphthalmicAkorn1990-09-01Not applicableUs
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
Camellia Cleansing BalmMineral oil (54.0999 g/100mL)SalveTopicalTov Co., Ltd2016-11-07Not applicableUs
FleetMineral oil (100 g/100mL) + Witch hazel (5 g/1)KitTopicalC.B. Fleet Company, Inc.2019-02-15Not applicableUs
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
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
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
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
Pyung Gang Ato SoonMineral oil (0.45 g/45mL)CreamTopicalPyung Gang Oriental Medical Clinic2015-04-02Not applicableUs
Pyung Gang Ato SoonMineral oil (0.45 g/45g)CreamTopicalPyung Gang Oriental Medical Clinic2015-04-02Not applicableUs
Categories
UNII
T5L8T28FGP
CAS number
8042-47-5

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.

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.

Additional Data Available
Adverse Effects

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

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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
Toxicity
Not Available
Affected organisms
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
1alpha-Hydroxyvitamin D5Mineral oil can cause a decrease in the absorption of 1alpha-Hydroxyvitamin D5 resulting in a reduced serum concentration and potentially a decrease in efficacy.
1alpha,24S-Dihydroxyvitamin D2Mineral oil can cause a decrease in the absorption of 1alpha,24S-Dihydroxyvitamin D2 resulting in a reduced serum concentration and potentially a decrease in efficacy.
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.
AgmatineThe therapeutic efficacy of Mineral oil can be decreased when used in combination with Agmatine.
AlcuroniumThe therapeutic efficacy of Mineral oil can be decreased when used in combination with Alcuronium.
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.
AlphacetylmethadolThe therapeutic efficacy of Mineral oil can be decreased when used in combination with Alphacetylmethadol.
Additional Data Available
  • Extended Description
    Extended Description

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  • Severity
    Severity

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  • Evidence Level
    Evidence Level

    A rating for the strength of the evidence supporting each drug interaction.

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  • Action
    Action

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Food Interactions
Not Available

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. [PubMed:14555442]
  2. Kleiman N (2018). Dry Skin. In Compendium of Therapeutic Choices for Minor Ailments (2nd ed.). Canadian Pharmacists Association.
External Links
PubChem Substance
347911096
Wikipedia
Mineral_oil
ATC Codes
A06AA01 — Liquid paraffinA06AA51 — Liquid paraffin, combinations
AHFS Codes
  • 84:24.12 — Basic Ointments and Protectants
  • 56:12.00 — Cathartics and Laxatives
MSDS
Download (48 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1CompletedTreatmentSkin and Connective Tissue Diseases1
1, 2CompletedTreatmentMelanoma1
2CompletedTreatmentAtopic Dermatitis (AD)1
2, 3CompletedTreatmentAbstinence Syndrome / Behavior, Addictive1
4CompletedBasic ScienceInflammatory Reaction1
4CompletedTreatmentDry Eye Syndrome (DES)1
4CompletedTreatmentDry Eye Syndromes1
4Unknown StatusTreatmentDermatitis, Contact / Dermatitis, Occupational1
Not AvailableCompletedPreventionDry Eye1
Not AvailableTerminatedTreatmentFunctional Constipation1
Not AvailableUnknown StatusDiagnosticHirschsprung's Disease1
Not AvailableUnknown StatusTreatmentDry Eye Syndrome (DES)1
Not AvailableUnknown StatusTreatmentPain1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
LiquidOral
OilTopical99.9 g/100mL
SuspensionTopical
LiquidTopical
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
KitOphthalmic
LotionTopical
OintmentRectal; Topical
EnemaRectal
OintmentTopical
GelTopical
LiquidOral
CreamRectal
SolutionTopical
LiquidOral; Topical
LiquidOral1000 mg/1mL
LiquidTopical1000 mg/1mL
LiquidTopical8 g/100mL
LiquidOral2.12 g/5mL
LiquidOral2.5 mL/5mL
GelOral
LiquidTopical100 %
EmulsionOral
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 mL/15mL
OilOral; Topical15 mg/15mL
OilOral; Topical15 mg/15mg
OilRectal100 g/100g
SolutionOral1000 mg/1mL
OilTopical471.99 g/472mL
SolutionOral
CreamTopical
LiquidTopical
OilTopical327.54 g/410mL
OilOral1 mg/1mL
OilTopical99.9 mL/100mL
OilOral999 mg/1mL
EnemaRectal100 g/100mL
CreamTopical0.45 g/45g
CreamTopical0.45 g/45mL
KitTopical
EmulsionOphthalmic
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
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

Taxonomy

Classification
Not classified

Drug created on December 03, 2015 09:51 / Updated on November 11, 2019 07:05