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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

PETROLATUM: 352 Adverse Event Reports & Safety Profile

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352
Total FAERS Reports
28 (8.0%)
Deaths Reported
57
Hospitalizations
352
As Primary/Secondary Suspect
15
Life-Threatening
13
Disabilities
American Consumer Products ...
Manufacturer

Route: TOPICAL · Manufacturer: American Consumer Products Corp · HUMAN OTC DRUG · FDA Label: Available

First Report: 19660624 · Latest Report: 20250912

What Are the Most Common PETROLATUM Side Effects?

#1 Most Reported
Drug ineffective
86 reports (24.4%)
#2 Most Reported
Rash
31 reports (8.8%)
#3 Most Reported
Pruritus
25 reports (7.1%)

All PETROLATUM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 86 24.4% 3 12
Rash 31 8.8% 3 12
Pruritus 25 7.1% 3 11
Condition aggravated 20 5.7% 2 6
Erythema 20 5.7% 3 8
Drug hypersensitivity 16 4.6% 3 4
Off label use 16 4.6% 4 7
Lip swelling 15 4.3% 0 6
Product use in unapproved indication 13 3.7% 3 6
Therapeutic response decreased 13 3.7% 0 0
Coeliac disease 12 3.4% 0 0
Pain 12 3.4% 1 2
Product complaint 12 3.4% 0 0
Skin exfoliation 12 3.4% 0 4
Blister 11 3.1% 3 7
Toxic epidermal necrolysis 11 3.1% 8 4
Dermatitis atopic 10 2.8% 0 8
Dyspepsia 10 2.8% 2 10
Lip pain 10 2.8% 0 5
Wrong technique in product usage process 10 2.8% 0 0

Who Reports PETROLATUM Side Effects? Age & Gender Data

Gender: 70.7% female, 29.3% male. Average age: 52.3 years. Most reports from: US. View detailed demographics →

Is PETROLATUM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 3 0 3
2004 5 3 5
2005 2 0 0
2009 1 0 1
2010 1 0 1
2013 1 1 1
2014 6 0 1
2015 20 0 9
2016 10 1 3
2017 11 0 4
2018 20 1 3
2019 7 0 1
2020 3 0 1
2021 6 0 0
2022 6 0 0
2023 11 0 1
2024 1 0 1
2025 8 4 4

View full timeline →

What Is PETROLATUM Used For?

IndicationReports
Product used for unknown indication 81
Chapped lips 22
Lip dry 21
Psoriasis 15
Dry skin 10
Eczema 10
Oedema 6
Skin fissures 6
Dermatitis diaper 5
Pruritus 5

PETROLATUM vs Alternatives: Which Is Safer?

PETROLATUM vs PEVONEDISTAT PETROLATUM vs PEXIDARTINIB PETROLATUM vs PHENACETIN PETROLATUM vs PHENAZOPYRIDINE PETROLATUM vs PHENCYCLIDINE PETROLATUM vs PHENELZINE PETROLATUM vs PHENOBARBITAL PETROLATUM vs PHENOLPHTHALEIN PETROLATUM vs PHENOTHIAZINE PETROLATUM vs PHENPROCOUMON

Official FDA Label for PETROLATUM

Official prescribing information from the FDA-approved drug label.

Drug Description

VASELINE BABY HEALING JELLY - (petrolatum) jelly

FDA Approved Uses (Indications)

Uses For the temporary relieve of local itching and discomfort associated with hemorrhoids. Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues. Temporarily protects irritated areas. Temporarily relieves burning. Provides temporary relief from skin irritations. Temporarily provides a coating for relief of anorectal discomforts. Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful. Temporarily protects inflamed perianal skin. Temporarily relieves the symptoms of perianal skin irritation.

Dosage & Administration

Directions For skin protectant use: apply as needed For incontinence or diaper rash: Change wet and soiled undergarments promptly Gently cleanse affected skin, and allow to dry Apply ointment liberally as often as necessary, with each undergarment change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Directions For skin protectant use: apply as needed For incontinence or diaper rash: Change wet and soiled undergarments promptly Gently cleanse affected skin, and allow to dry Apply ointment liberally as often as necessary, with each undergarment change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Known Adverse Reactions

ADVERSE REACTION The basic idea: highly rated products at low prices. This product restores smooth, healthy skin. It is paraben, phthalate and quaternium 15 free.* *This product would not normally contain parabens. DISTRIBUTED BY: Amazon.com Services, LLC Seattle, WA 98109 1-877-485-0385 amazon ©2021 Amazon.com, Inc. or its afiliates. All rights reserved. www.amazon.com/amazonbasics "Alexa, reorder Amazon Basics Healing Ointment."

Warnings

Warnings For external use and/or intrarectal use only Do not use If allergic to any of the ingredients When using this product Do not exceed the recommended daily dosage unless as directed by a doctor. Do not use the product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly. Stop use and ask a doctor if Bleeding occurs Condition worsens or does not improve within 7 days Do not use during pregnancy or when breast feeding. Consult a health professional before use. Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away Do not use otherwise than as directed.

Precautions

Stop use and ask a doctor if condition worsens, symptoms last longer than 7 days or clear up and occur again within a few days

Active Ingredient

Active Ingredient: Active Ingredient: Purpose Petrolatum USP 99%............................................................................Skin Protectant

Inactive Ingredients

Inactive ingredients water (aqua), glycerin, glyceryl monostearate, PEG-100 stearate, stearic acid, ceteareth 20, trieathanolamine, lanolin alcohol, fragrance, acrylates/C 10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, cocoa butter, tocopheryl acetate, disodium EDTA 110781 DISTRIBUTED BY GREENBRIER INTERNATIONAL, INC. 500 VOLVO PARKWAY, CHESAPEAKE, VA 23320 MADE IN INDIA Skin Softener Hydrates & Evens Skin Tone COCOA BUTTER Petroleum Jelly C. No. DNH/COS/DNH/130 1222101976