White Petrolatum 100 g/100g
White petrolatum · CREAM · Sled Distribution, LLC
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
Altaire Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Brassica Pharma Pvt Ltd
Lack of Assurance of Sterility
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.
AbbVie Inc.
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Consumer Product Partners, LLC
Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
Global Pharma Healthcare Private Limited
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Brassica Pharma Pvt Ltd
Lack of Assurance of Sterility
OraLabs, Incorporated
Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.
Brassica Pharma Pvt Ltd
Lack of Assurance of Sterility
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.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)