Drugplain

Salicylic Acid 40 mg/241

Medicated Plantar Wart Remover · PATCH · Topco Associates LLC

10 Recalls on Record
Plain English

Salicylic Acid is a patch containing medicated plantar wart remover at 40 mg/241, taken topical. Manufactured by Topco Associates LLC.

Key Facts

Brand Name
Salicylic Acid
Generic Name
Medicated Plantar Wart Remover
NDC Code (Product)
36800-378
Manufacturer
Topco Associates LLC
Strength
40 mg/241
Dosage Form
PATCH
Route
TOPICAL
Marketing Status
Application #
M028
Marketing Start
12/06/2017

Recall History

10 Recalls on Record
Class II05/01/2013

Medicis Pharmaceutical Corp

cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy

TerminatedVoluntary: Firm initiated
Class III10/15/2012

Valeant Pharmaceuticals

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.

TerminatedVoluntary: Firm initiated
Class III03/20/2017

Valeant Pharmaceuticals North America LLC

Discoloration.

TerminatedVoluntary: Firm initiated
Class III05/07/2012

Guthy-Renker LLC

Subpotent Drug: Salicylic acid is subpotent.

TerminatedVoluntary: Firm initiated
Class II02/10/2017

Synergy Rx

Lack of Assurance of Sterility: There are also CGMP Deviations.

TerminatedVoluntary: Firm initiated
Class II10/09/2020

Milbar Laboratories, Inc.

GMP Deviations

TerminatedVoluntary: Firm initiated
Class III07/06/2020

Allergan PLC

SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.

TerminatedVoluntary: Firm initiated
Class II10/19/2015

Western Drug

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II12/06/2021

Edge Pharma, LLC

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II04/04/2016

Keystone Laboratories Inc

Microbial Contamination of Non-Sterile Products: Failed S.aureus test.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

pruritus201 reports
vomiting201 reports
drug ineffective192 reports
condition aggravated191 reports
headache182 reports
infection177 reports
weight decreased176 reports
hypertension171 reports
dyspnoea169 reports
pain169 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use For the removal of common warts. The common wart has a rough 'cauliflower-like' appearance..

Dosage & Administration

Directions after washing affected area, soak wart for 5 minutes in comfortably warm water dry area thoroughly if necessary cut medicated patch to fit wart apply adhesive side down of patch onto wart cover patch with pad to conceal area repeat this procedure every 48 hours as needed (until wart is removed) for up to 12 weeks

Warnings

Warnings For external use only. Do not use this product if you are a diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist Do not use on irritated, infected or reddened skin moles, birthmarks and warts with hair growing from them on genital warts and warts on the face mucous membranes ​Keep out of reach of children. ​ If swallowed, get medical help or contact a Poison Control Center right away. If discomfort persists see your doctor or podiatrist.

Frequently Asked Questions

What is Salicylic Acid used for?

Salicylic Acid contains Medicated Plantar Wart Remover. It is a patch taken topical. Consult your doctor for specific uses.

Is Salicylic Acid a controlled substance?

Salicylic Acid is not classified as a controlled substance by the DEA.

What is the generic name for Salicylic Acid?

The generic name for Salicylic Acid is Medicated Plantar Wart Remover. There are no other listed brand versions of Medicated Plantar Wart Remover.

What is the NDC code for Salicylic Acid 40 mg/241?

The NDC (National Drug Code) for Salicylic Acid 40 mg/241 is 36800-378, listed by Topco Associates LLC.

Product NDC

36800-378

Package NDC

36800-378-24

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)