Petrolatum

Identification

Name

Petrolatum

Accession Number

DB11058  (DB09520)

Type

Small Molecule

Groups

Approved, Investigational

Description

A colloidal system of semisolid hydrocarbons obtained from petroleum. It is used as an ointment base, topical protectant, and lubricant.

Synonyms

• Multi-hydrocarbon
• Paraffinum album
• Paraffinum flavum
• Petrolatum base
• Petrolatum, white
• Petrolatum,amber
• Petrolatum,white
• Petroleum jelly
• Soft paraffin
• White petrolatum
• White, soft paraffin
• Yellow soft paraffin

Over the Counter Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End
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A and D	Ointment	76 g/100g	Topical	Safetec of America, Inc.	2019-11-01	Not applicable
A and D	Ointment	937.5 mg/1g	Topical	H&H Laboratories, Inc.	2012-05-14	Not applicable
A and D	Ointment	937.5 mg/1g	Topical	Henry Schein, Inc.	2011-12-04	Not applicable
A and D	Ointment	0.93 g/1g	Topical	Gentell, Inc.	2019-05-25	Not applicable
A and D plus E	Ointment	0.9985 g/1g	Topical	Gentell, Inc.	2014-11-03	Not applicable
A and D plus E	Ointment	937.5 mg/1g	Topical	H&H Laboratories, Inc.	2012-05-14	Not applicable
Advaced First Aid A and D	Ointment	937.5 mg/1g	Topical	Advanced First Aid, Inc.	2015-04-07	Not applicable
Advanced Healing	Ointment	0.340 g/1g	Topical	Walgreen Co	2008-03-28	Not applicable
Advanced Healing	Ointment	340 mg/100g	Topical	Walgreen Co	2013-08-27	Not applicable
Advanced Healing	Ointment	340 mg/100g	Topical	Vi-Jon	2017-03-20	Not applicable

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

Name	Ingredients	Dosage	Route	Labeller	Marketing Start	Marketing End
7 Select Hemorrhoidal Original Strength	Petrolatum (749 mg/1g) + Mineral oil (140 mg/1g) + Phenylephrine hydrochloride (2.5 mg/1g)	Ointment	Topical	7-ELEVEN, INC.	2016-12-07	Not applicable
A and D Diaper Rash and Skin Protectant	Petrolatum (0.53 mg/1g) + Lanolin (0.15 mg/1g)	Cream	Topical	Natureplex, LLC	2014-11-12	Not applicable
A and D First Aid	Petrolatum (469.9 mg/1g) + Lanolin (136.4 mg/1g)	Ointment	Topical	Bayer HealthCare LLC	2003-06-04	Not applicable
A and D First Aid	Petrolatum (469.9 mg/1g) + Lanolin (136.4 mg/1g)	Ointment	Topical	Famar Montreal Inc	2003-06-04	Not applicable
A and D Original	Petrolatum (469.9 mg/1g) + Lanolin (136.4 mg/1g)	Ointment	Topical	Famar Montreal Inc	2009-12-25	Not applicable
A and D Original	Petrolatum (469.9 mg/1g) + Lanolin (136.4 mg/1g)	Ointment	Topical	Bayer Healthcare Llc.	2009-12-25	Not applicable
A D and L Original Diaper Rash Skin	Petrolatum (53.4 g/100g) + Lanolin (15.5 g/100g)	Ointment	Topical	Harmon Stores	2014-09-01	Not applicable
A+d Diaper Rash Ointment	Petrolatum (53.4 %) + Lanolin (15.5 %)	Ointment	Topical	Schering Plough	1998-07-08	2014-07-31
Alexander's Rash Ease - for Babies	Petrolatum (88.7 %) + Zinc oxide (5 %)	Cream	Topical	Altacomp Enterprises Inc	2010-05-29	Not applicable
Alexander's Rash Ease - Sport Cream	Petrolatum (88.7 %) + Zinc oxide (5 %)	Cream	Topical	Altacomp Enterprises Inc	2017-09-17	Not applicable

Unapproved/Other Products

Name	Ingredients	Dosage	Route	Labeller	Marketing Start	Marketing End
Antiscar	Petrolatum (3 g/100g) + 13-cis-12-(3'-Carboxyphenyl)retinoic acid (2 g/100g) + Allantoin (2 g/100g) + Epigallocatechin gallate (.3 g/100g) + Onion (.5 g/100g)	Patch	Topical	Basiem	2015-04-01	2015-04-20
Elite	Petrolatum (30 g/100g) + Allantoin (2 g/100g) + Lidocaine (4 g/100g)	Patch	Topical	Meds Direct Rx Of Ny Llc	2015-01-31	2015-06-08
PCP 100 Kit	Petrolatum (0.76 g/1g) + Bisacodyl (5 mg/1) + Magnesium citrate (1.745 g/29.6mL) + Metoclopramide hydrochloride (10 mg/1) + Polyethylene glycol (17 g/17g)	Kit	Oral	Asclemed Usa, Inc.	2014-01-02	Not applicable
Preginot	Petrolatum (30 g/100g) + Allantoin (2 g/100g) + Lidocaine (4 g/100g)	Patch	Topical	Pharmaco Technology Llc	2015-04-01	2015-04-01
Premium Scar Patch	Petrolatum (30 g/100g) + Allantoin (2 g/100g) + Lidocaine (5 g/100g)	Patch	Topical	Alivio Medical Products, Llc	2015-03-15	Not applicable
Renuu NL	Petrolatum (30 g/100g) + Allantoin (2 g/100g)	Patch	Topical	Patchwerx Labs	2014-04-15	Not applicable
Renuu Patch	Petrolatum (30 g/100g) + Allantoin (2 g/100g) + Lidocaine (5 g/100g)	Patch	Topical	Patchwerx Labs	2014-04-15	Not applicable
Scar Patch	Petrolatum (30 g/100g) + Allantoin (2 g/100g) + Lidocaine (5 g/100g)	Patch	Topical	Binger Consulting Corporation	2014-12-01	2016-07-31
Scar Patch	Petrolatum (30 g/100g) + Allantoin (2 g/100g) + Lidocaine hydrochloride (4 g/100g)	Patch	Topical	Binger Consulting Corporation	2014-12-01	2015-11-30
Vexa	Petrolatum (30 mg/1) + Allantoin (2 mg/1) + Lidocaine (4 mg/1)	Patch	Topical	Pharmaceutics Corporation	2015-03-19	Not applicable

Categories

• Basic Ointments and Protectants
• Compounds used in a research, industrial, or household setting
• Dermatologicals
• Emollients
• Ointment Bases
• Pharmaceutic Aids
• Pharmaceutical Preparations

UNII

4T6H12BN9U

CAS number

8009-03-8

Weight

Not Available

Chemical Formula

Not Available

InChI Key

Not Available

InChI

Not Available

IUPAC Name

Not Available

SMILES

Not Available

Pharmacology

Indication

For use as an over the counter skin protectant ^Label. Commonly used to treat diaper rash and chapped lips ^{Label 1}.

Associated Therapies

• Skin protectant

Pharmacodynamics

Displaces water and acts as a barrier against harsh environmental conditions like wind ^{Label 1}.

Mechanism of action

Not Available

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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

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

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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.

Not Available

Food Interactions

Not Available

References

General References

1. FDA Monograph: Petrolatum [Link]

External Links

KEGG Drug

D05304

PubChem Substance

347911097

RxNav

8091

Drugs.com

Drugs.com Drug Page

Wikipedia

Petroleum_jelly

AHFS Codes

• 84:24.12 — Basic Ointments and Protectants

FDA label

Download (230 KB)

MSDS

Download (47.7 KB)

Clinical Trials

Clinical Trials

Phase	Status	Purpose	Conditions	Count
0	Completed	Treatment	Intertrigo	1
0	Not Yet Recruiting	Treatment	Retinitis Pigmentosa (RP)	1
0	Recruiting	Treatment	Hypertrophic Scars / Scarring / Surgery--Complications / Surgical Incision / Surgical Site Infections / Surgical Wound	1
0	Recruiting	Treatment	Keloid Scars	1
0	Withdrawn	Treatment	Chemical Peel	1
1	Completed	Not Available	Healthy Volunteers	1
1	Completed	Other	Psoriasis Vulgaris (Plaque Psoriasis)	1
1	Completed	Other	Skin and Connective Tissue Diseases	1
1	Completed	Treatment	Healthy Volunteers	1
1, 2	Terminated	Prevention	Radiodermatitis	1
2	Recruiting	Prevention	Staphylococcus	1
2	Recruiting	Treatment	Back Pain, Unspecified / Endometriosis / Fibromyalgia Syndrome / Headaches, Tension / Interstitial Cystitis / Irritable Bowel Syndrome (IBS) / Migraine / Myalgic Encephalomyelitis (ME) / Temporomandibular Disorders / Vestibulodynia	1
2	Recruiting	Treatment	Hives	1
2, 3	Not Yet Recruiting	Treatment	Psoriasis	1
3	Completed	Treatment	Superficial Partial Thickness Burns	1
4	Active Not Recruiting	Treatment	Type 2 Diabetes Mellitus / Xerosis Cutis	1
4	Completed	Basic Science	Inflammatory Reaction	1
4	Completed	Prevention	Skin Diseases	1
4	Completed	Treatment	Atopic Dermatitis (AD)	1
4	Completed	Treatment	Diaper Rash	1
4	Completed	Treatment	Dry Eye Syndrome (DES)	1
4	Completed	Treatment	Dry Eye Syndromes	1
4	Completed	Treatment	Hypertrophic Scars	1
4	Completed	Treatment	Pityriasis Alba	1
4	Recruiting	Treatment	Atopic Dermatitis (AD) / Dermatitis, Eczematous	1
Not Available	Completed	Basic Science	Skin Diseases	1
Not Available	Completed	Treatment	Breast Cancer / Radiation Dermatitis	1
Not Available	Completed	Treatment	Ecchymosis	1
Not Available	Completed	Treatment	Foot Eczema / Hand Eczema	1
Not Available	Recruiting	Not Available	Burn Wounds / Chronic / Chronic Wounds / Diabetic Foot Ulcers (DFU) / Pressure Ulcers / Venous Leg Ulcer (VLU) / Wound site	1
Not Available	Terminated	Prevention	Dry Eye	1
Not Available	Unknown Status	Prevention	Dermatitis, Eczematous	1
Not Available	Unknown Status	Treatment	Dry Eye Syndrome (DES)	1
Not Available	Unknown Status	Treatment	Seborrheic Dermatitis	1

Pharmacoeconomics

Manufacturers

Not Available

Packagers

Not Available

Dosage forms

Form	Route	Strength
Ointment	Topical	0.93 g/1g
Ointment	Topical	937.5 mg/1g
Ointment	Topical	0.9985 g/1g
Ointment	Topical	340 mg/100g
Ointment	Topical	340 mg/1g
Spray	Topical	36 g/100g
Ointment	Topical	430 mg/1g
Spray	Topical	360 mg/1g
Jelly	Topical	99.8 g/100g
Jelly	Topical	99.5 g/100g
Ointment	Topical	100 g/44.28g
Ointment	Topical	540 mg/1g
Ointment	Topical	54 mg/1g
Cream	Topical	99 g/100g
Ointment	Topical	99.93 %
Ointment	Topical	84.3 g/100g
Ointment	Topical	84.3 %
Ointment	Topical	0.511 g/1g
Ointment	Topical	511 mg/1g
Cream	Topical	43 g/1000g
Ointment	Topical	960 mg/1g
Ointment	Topical	620 mg/1g
Stick	Topical
Ointment	Topical	34.85 g/85g
Stick	Topical	41 mg/1g
Ointment	Topical	43.75 mg/1g
Ointment	Topical	.96 g/1g
Salve	Topical
Cream	Topical	0.61 g/1g
Ointment	Topical	46.5 g/100g
Lipstick	Topical	619.3 mg/1g
Stick	Topical	450 mg/1g
Kit	Topical
Stick	Oral
Jelly	Topical
Gel	Topical
Jelly	Topical	1 g/1g
Jelly	Topical	998 mg/1g
Salve	Topical	27.6 g/28.4g
Lotion	Topical	5 g/100g
Jelly	Topical	30 g/100g
Jelly	Topical	.30 g/100g
Jelly	Topical	.30 mg/100g
Cream	Topical	30 g/100g
Ointment	Topical	710 mg/1g
Ointment	Topical	71.5 %
Ointment	Topical	865 mg/1g
Cream	Topical	300 mg/1mL
Ointment	Topical	410 mg/1g
Ointment	Topical	.041 g/.1g
Cream	Topical	33 g/100g
Jelly	Topical	99 g/100g
Jelly	Topical	98.3 g/100g
Ointment	Topical	85 g/100g
Ointment	Topical	33 g/100g
Ointment	Topical	44 g/100g
Ointment	Topical	713 mg/1g
Ointment	Topical	703.2 mg/1g
Jelly	Topical	226 g/226g
Ointment	Ophthalmic
Lotion	Topical	28.4 g/50g
Cream	Topical	28.4 g/50g
Gel	Topical	1 g/85g
Ointment	Topical	600 g/1000g
Ointment	Topical	77.6 g/1000g
Ointment	Topical	0.41 g/1g
Stick	Topical	45.0 mg/1g
Kit	Ophthalmic
Lipstick	Topical
Gel	Topical	70.9787 g/71g
Ointment	Topical	87.32 g/118g
Cream	Rectal; Topical
Ointment	Topical	450 mg/1mL
Cream	Topical	50.74 g/100g
Ointment	Topical	340 g/1g
Ointment	Topical	41 kg/1g
Ointment	Topical	41 kg/100kg
Stick	Topical	670 mg/1g
Ointment	Rectal	93.3 g/100g
Ointment	Topical
Ointment	Topical	41.000 g/100g
Cream	Topical	45 g/100g
Cream	Topical	52.2 g/100g
Cream	Topical	430 mg/1g
Ointment	Topical	430 mg/1mL
Kit	Not applicable
Ointment	Topical	76 g/100g
Ointment	Topical	48 g/100mL
Stick	Topical	32.3 g/100g
Jelly	Topical	1000 mg/1g
Paste	Topical
Stick	Topical
Gel	Topical
Ointment	Topical	935 mg/1g
Ointment	Rectal; Topical
Ointment	Topical	604 mg/1mL
Ointment	Topical	60.3 mL/100mL
Spray	Topical	36 mL/120mL
Spray	Topical	36 g/120mL
Ointment	Topical	99.397 g/100g
Ointment	Topical	99.9 g/100g
Ointment	Topical	774 mg/1g
Lotion	Topical
Cream	Topical
Stick	Topical	45 mg/1g
Ointment	Topical	0.41 mg/1g
Kit	Oral
Ointment	Topical	49.9 g/1g
Jelly	Topical	170 g/170g
Gel	Topical	100 g/1g
Cream	Topical	69 mg/1g
Ointment	Topical	0.340 g/1g
Ointment	Topical	10 g/10g
Ointment	Topical	600 mg/1g
Jelly	Topical	1 mg/1g
Jelly	Topical	100 g/100g
Jelly	Topical	1000 mg/100g
Jelly	Topical	82.32 mg/1g
Jelly	Topical	838 g/1g
Jelly	Topical	99.8 g/100kg
Jelly	Topical
Ointment	Topical	100 %
Ointment	Topical	99.99 %
Jelly	Topical	99.9 g/100g
Jelly	Topical	99.9 1/100g
Ointment	Topical	99.6 %
Paste		650 mg/1mL
Ointment	Topical	99.5 g/100g
Ointment	Topical	93.4 g/100g
Ointment	Topical	75 g/100g
Ointment	Topical	0.99 g/1g
Cream	Topical	0.6 g/1g
Jelly	Topical	0.99 g/1g
Liquid	Topical
Ointment	Topical	500 mg/1g
Paste	Topical	59 g/100g
Paste	Topical	57 g/100g
Ointment	Topical	83 mg/1g
Ointment	Topical	86 mg/1g
Cream	Topical	41 g/100g
Jelly	Topical	410 mg/1g
Ointment	Topical	41 g/100g
Ointment	Topical	420 mg/1g
Jelly	Topical	41.0 g/100g
Ointment	Topical	987.89 mg/1g
Cream	Rectal
Gel	Topical	99.98 mg/1g
Cream	Topical	43 g/100g
Lotion	Topical	39.9 g/133mL
Ointment	Topical	93.5 g/100g
Ointment	Topical	23 g/71g
Jelly	Topical	225 g/225g
Jelly	Topical	110 g/110g
Ointment	Topical	92.8 g/100g
Ointment	Topical	98.3 g/100g
Gel	Ophthalmic
Jelly	Topical	99.7 g/100g
Cream	Cutaneous	65 g/100g
Ointment	Rectal
Jelly	Topical	99.6 g/100g
Ointment	Topical	100 g/100g
Jelly	Topical	99.96 g/100g
Patch	Topical
Ointment	Topical	.948 g/1g
Ointment	Topical	.948 mL/1mL
Ointment	Topical	0.948 mL/1mL
Ointment	Topical	30.8 g/56g
Ointment	Topical	929.3 mg/1g
Ointment	Topical	.75 g/1g
Ointment	Topical	.76 g/1g
Ointment	Topical	.93 g/1g
Ointment	Topical	0.76 g/1g
Ointment	Topical	930 mg/1g
Ointment	Topical	93 g/100g
Lotion	Topical	0.41 g/1g
Ointment	Topical	42 g/100g
Ointment	Topical	1 g/1g
Ointment	Topical	5 [USP'U]/5g
Ointment	Topical	50 g/100g
Cream	Topical
Paste	Topical
Ointment	Topical
Ointment	Topical	1000 mg/1g
Stick	Topical	30.0 mg/1g
Cream	Topical	99.7 g/100g
Jelly	Topical	38 g/127g
Cream	Topical	59 g/198g

Prices

Not Available

Patents

Patent Number	Pediatric Extension	Approved	Expires (estimated)
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US8147852	No	2012-04-03	2028-03-30

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Filed On
Filed On
The date on which a patent was filed with the relevant government.
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Properties

State

Solid

Experimental Properties

Property	Value	Source
melting point (°C)	38-60	MSDS
water solubility	Insoluble	MSDS

Predicted Properties

Not Available

Predicted ADMET features

Not Available

Spectra

Mass Spec (NIST)

Not Available

Spectra

Not Available

Taxonomy

Classification

Not classified

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Drug created on December 03, 2015 09:51 / Updated on April 09, 2020 00:17