Drugplain

White Petrolatum 100 g/100g

White petrolatum · CREAM · Sled Distribution, LLC

10 Recalls on Record
Plain English

White Petrolatum is a moisturizing cream applied directly to the skin to help treat and prevent dry skin and minor skin irritation. It works by forming a protective barrier on the skin to lock in moisture.

Key Facts

Brand Name
White Petrolatum
Generic Name
White petrolatum
NDC Code (Product)
81417-004
Manufacturer
Sled Distribution, LLC
Strength
100 g/100g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M016
Marketing Start
08/29/2022

Recall History

10 Recalls on Record
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II01/30/2024

Brassica Pharma Pvt Ltd

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II08/24/2015

Allergan Sales, LLC

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

TerminatedVoluntary: Firm initiated
Class II09/16/2024

AbbVie Inc.

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

OngoingVoluntary: Firm initiated
Class II05/28/2024

Consumer Product Partners, LLC

Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile

TerminatedVoluntary: Firm initiated
Class I02/24/2023

Global Pharma Healthcare Private Limited

Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.

OngoingVoluntary: Firm initiated
Class II01/30/2024

Brassica Pharma Pvt Ltd

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II11/25/2019

OraLabs, Incorporated

Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.

TerminatedVoluntary: Firm initiated
Class II01/30/2024

Brassica Pharma Pvt Ltd

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II08/24/2015

Allergan Sales, LLC

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pyrexia69 reports
rash62 reports
pneumonia58 reports
diarrhoea54 reports
nausea46 reports
anaemia42 reports
febrile neutropenia42 reports
cellulitis39 reports
vomiting38 reports
sepsis35 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses: Helps treat and prevent diaper rash Helps seal out wetness Temporarily protects minor * cuts * scrapes * burns Temporarily helps protect and relieve chapped and cracked skin or lips Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash With each diaper change, especially at bedtime when exposure to wet diapers may be prolonged.

Dosage & Administration

Directions: Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply as needed.

Warnings

Warnings: For external use only. When using this product do not get into eyes. Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again in a few days. Do not use on deep puncture wounds animal bites serious burns. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is White Petrolatum used for?

White Petrolatum is a moisturizing cream applied directly to the skin to help treat and prevent dry skin and minor skin irritation. It works by forming a protective barrier on the skin to lock in moisture.

Is White Petrolatum a controlled substance?

White Petrolatum is not classified as a controlled substance by the DEA.

What is the generic name for White Petrolatum?

The generic name for White Petrolatum is White petrolatum. There are 11 other brand versions of White petrolatum.

What is the NDC code for White Petrolatum 100 g/100g?

The NDC (National Drug Code) for White Petrolatum 100 g/100g is 81417-004, listed by Sled Distribution, LLC.