Drugplain

Topical Cream 4 g/100g

Lidocaine · CREAM · BLOOMWELL GARDENS LLC

10 Recalls on RecordCurrently in Shortage
Plain English

Lidocaine cream is a local anesthetic that numbs the skin and is used to relieve pain, itching, and discomfort from minor cuts, burns, insect bites, and other skin irritations. It is available over-the-counter and is applied directly to the affected area of skin.

Key Facts

Brand Name
Topical Cream
Generic Name
Lidocaine
NDC Code (Product)
85284-002
Manufacturer
BLOOMWELL GARDENS LLC
Strength
4 g/100g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M017
Drug Class
Amide Local Anesthetic [EPC]; Antiarrhythmic [EPC]
Marketing Start
06/16/2025

Recall History

10 Recalls on Record
Class II11/21/2012

Taro Pharmaceuticals U.S.A., Inc.

Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.

TerminatedVoluntary: Firm initiated
Class II11/16/2017

KRS Global Biotechnology, Inc

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

TerminatedVoluntary: Firm initiated
Class II03/28/2018

Elroselabs Inc.

cGMP Deviations

TerminatedVoluntary: Firm initiated
Class II11/16/2017

KRS Global Biotechnology, Inc

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

TerminatedVoluntary: Firm initiated
Class II12/06/2021

Edge Pharma, LLC

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II12/18/2019

MPRX, Inc. dba Medical Park Pharmacy

Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.

TerminatedVoluntary: Firm initiated
Class II02/12/2015

Health Innovations Pharmacy, Inc

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

TerminatedVoluntary: Firm initiated
Class II11/16/2017

KRS Global Biotechnology, Inc

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

TerminatedVoluntary: Firm initiated
Class II11/09/2022

DISCOVERY PHARMA LLC

CGMP deviations

TerminatedVoluntary: Firm initiated
Class II11/16/2017

KRS Global Biotechnology, Inc

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

TerminatedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Temporarily helps reduce discomfort from : Minor burns, Insect bites,linor skin irritations,Post-shaving or grooming sensitivity,External itching or rash due to dry skin

Dosage & Administration

Directions ▪ Adults and children over 12 years: ▪ Apply a thin layer to affected area not more than 3–4 times daily ▪ Children under 12 years: Consult a doctor before use ▪ Wash hands after application

Warnings

Warnings For external use only

Frequently Asked Questions

What is Topical Cream used for?

Lidocaine cream is a local anesthetic that numbs the skin and is used to relieve pain, itching, and discomfort from minor cuts, burns, insect bites, and other skin irritations. It is available over-the-counter and is applied directly to the affected area of skin.

Is Topical Cream a controlled substance?

Topical Cream is not classified as a controlled substance by the DEA.

What is the generic name for Topical Cream?

The generic name for Topical Cream is Lidocaine. There are 12 other brand versions of Lidocaine.

What is the NDC code for Topical Cream 4 g/100g?

The NDC (National Drug Code) for Topical Cream 4 g/100g is 85284-002, listed by BLOOMWELL GARDENS LLC.