PETROLATUM .098 g/20g
iShanCare Hemorrhoid Cream · CREAM · Shenzhen Ishan Technology Co., Ltd
PETROLATUM is a cream containing ishancare hemorrhoid cream at .098 g/20g, taken topical. Manufactured by Shenzhen Ishan Technology Co., Ltd.
Key Facts
- Brand Name
- PETROLATUM
- Generic Name
- iShanCare Hemorrhoid Cream
- NDC Code (Product)
73076-129- Manufacturer
- Shenzhen Ishan Technology Co., Ltd
- Strength
- .098 g/20g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Marketing Start
- 12/02/2021
Recall History
Zhejiang Jingwei Pharmaceutical Co., Ltd.
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Apipharma
CGMP Deviations
Altaire Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Brassica Pharma Pvt Ltd
Lack of Assurance of Sterility
DermaRite Industries, LLC
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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.
US Pharmaceuticals Inc.
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
US Pharmaceuticals Inc.
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
AbbVie Inc.
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Altaire Pharmaceuticals, Inc.
Lack of Assurance of Sterility
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, espicially 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
Frequently Asked Questions
What is PETROLATUM used for?
PETROLATUM contains iShanCare Hemorrhoid Cream. It is a cream taken topical. Consult your doctor for specific uses.
Is PETROLATUM a controlled substance?
PETROLATUM is not classified as a controlled substance by the DEA.
What is the generic name for PETROLATUM?
The generic name for PETROLATUM is iShanCare Hemorrhoid Cream. There are 1 other brand versions of iShanCare Hemorrhoid Cream.
What is the NDC code for PETROLATUM .098 g/20g?
The NDC (National Drug Code) for PETROLATUM .098 g/20g is 73076-129, listed by Shenzhen Ishan Technology Co., Ltd.