Drugplain

Dimethicone 12 mg/mL

Dimethicone · LOTION · Meijer, Inc.

10 Recalls on Record
Plain English

Dimethicone is a lotion containing dimethicone at 12 mg/mL, taken topical. Manufactured by Meijer, Inc..

Key Facts

Brand Name
Dimethicone
Generic Name
Dimethicone
NDC Code (Product)
79481-0496
Manufacturer
Meijer, Inc.
Strength
12 mg/mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M016
Marketing Start
06/05/2023

Recall History

10 Recalls on Record
Class II07/15/2019

La Fresh Group, Inc.

Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites.

TerminatedVoluntary: Firm initiated
Class II08/27/2025

DermaRite Industries, LLC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

OngoingVoluntary: Firm initiated
Class I07/29/2016

Sage Products LLC

Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.

TerminatedVoluntary: Firm initiated
Class II05/22/2018

Medline Industries Inc (Northpoint Services)

Microbial Contamination of a Non-Sterile Product.

TerminatedVoluntary: Firm initiated
Class II06/10/2024

Brands International Corporation

Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination

OngoingVoluntary: Firm initiated
Class III02/21/2017

Bayer HealthCare Pharmaceuticals, Inc.

Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.

TerminatedVoluntary: Firm initiated
Class II08/27/2014

Sage Products Inc

Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.

TerminatedVoluntary: Firm initiated
Class II08/27/2025

DermaRite Industries, LLC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

OngoingVoluntary: Firm initiated
Class II07/29/2016

Sage Products LLC

CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective539 reports
macular degeneration453 reports
off label use357 reports
pyrexia349 reports
nausea328 reports
pain303 reports
malaise293 reports
weight decreased257 reports
abdominal pain231 reports
headache221 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for the relief of: acid indigestion heartburn sour stomach upset stomach due to these symptoms pressure and bloating commonly referred to as gas

Dosage & Administration

Directions shake well before using do not take more than 2 unit dose cups (60 mL) in 24 hours or use the maximum dosage for more than 2 weeks adults and children 12 years and older Take 30 mL, one unit dose cup, one to two times daily, or as directed by a doctor. children under 12 years consult a physician

Warnings

Warnings Do not take more than 2 unit dose cups (60 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a physician. Ask a doctor before use if you have kidney disease a magnesium-restricted diet Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than 2 weeks. Keep out of reach of children.

Frequently Asked Questions

What is Dimethicone used for?

Dimethicone contains Dimethicone. It is a lotion taken topical. Consult your doctor for specific uses.

Is Dimethicone a controlled substance?

Dimethicone is not classified as a controlled substance by the DEA.

What is the generic name for Dimethicone?

The generic name for Dimethicone is Dimethicone. There are 11 other brand versions of Dimethicone.

What is the NDC code for Dimethicone 12 mg/mL?

The NDC (National Drug Code) for Dimethicone 12 mg/mL is 79481-0496, listed by Meijer, Inc..