Mineral Oil 999 mg/mL
Mineral Oil · LIQUID · Strategic Sourcing Services LLC
Mineral Oil is a liquid containing mineral oil at 999 mg/mL, taken oral. Manufactured by Strategic Sourcing Services LLC.
Key Facts
- Brand Name
- Mineral Oil
- Generic Name
- Mineral Oil
- NDC Code (Product)
70677-1110- Manufacturer
- Strategic Sourcing Services LLC
- Strength
- 999 mg/mL
- Dosage Form
- LIQUID
- Route
- ORAL
- Marketing Status
- Application #
- M007
- Marketing Start
- 04/17/2023
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.
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.
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
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.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early aging caused by the sun
Dosage & Administration
Directions apply liberally 15 minutes before sun exposure. reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months of age: Ask a doctor Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses
Warnings
Warnings For external use only
Frequently Asked Questions
What is Mineral Oil used for?
Mineral Oil contains Mineral Oil. It is a liquid taken oral. Consult your doctor for specific uses.
Is Mineral Oil a controlled substance?
Mineral Oil is not classified as a controlled substance by the DEA.
What is the generic name for Mineral Oil?
The generic name for Mineral Oil is Mineral Oil. There are 11 other brand versions of Mineral Oil.
What is the NDC code for Mineral Oil 999 mg/mL?
The NDC (National Drug Code) for Mineral Oil 999 mg/mL is 70677-1110, listed by Strategic Sourcing Services LLC.
Other Mineral Oil Dosages
Other Mineral Brands
See all →- Hemorrhoidal14 g/100g85766-140
- Hemorrhoidal14 g/100g11822-0006
- Signature Care Hemorrhoidal140 mg/g21130-789
- REFRESH LACRI-LUBE425 mg/g0023-0312
- CAREALL Hemorrhoidal140 mg/g51824-079
- Pure and Gentle100 g/100mL53329-013
- HemorrhoidalOintment14 g/100g69396-083
- Family wellness14 g/100g69571-006
- Equaline Hemorrhoidal14 g/100g41163-188
- Sunmark Mineral Oil Laxative118 g/118mL49348-185
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)