PETROLATUM: 352 Adverse Event Reports & Safety Profile
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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?
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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is PETROLATUM Used For?
| Indication | Reports |
|---|---|
| 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?
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