Drugplain

Pain Relief Patch 80 mg/1001

Pain Relief Patch · PATCH · QUEST USA CORP.

4 Recalls on Record
Plain English

Pain Relief Patch is a patch containing pain relief patch at 80 mg/1001, taken topical. Manufactured by QUEST USA CORP..

Key Facts

Brand Name
Pain Relief Patch
Generic Name
Pain Relief Patch
NDC Code (Product)
78691-141
Manufacturer
QUEST USA CORP.
Strength
80 mg/1001
Dosage Form
PATCH
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
06/14/2024

Recall History

4 Recalls on Record
Class II09/17/2015

The Mentholatum Co.

Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly or cover with any type of wrap except clothing and "do use with a heating pad or with other heat sources in the Drug Facts panel "Warning" section

TerminatedVoluntary: Firm initiated
Class II10/24/2024

Unexo Life Sciences Private Limited

cGMP Deviations

TerminatedVoluntary: Firm initiated
Class II05/19/2020

Wuhan Bingbing Pharmaceutical Co., Ltd.

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

OngoingVoluntary: Firm initiated
Class II11/01/2024

JR Watkins

cGMP Deviations

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective4,233 reports
pain3,588 reports
nausea3,298 reports
fatigue3,076 reports
headache3,010 reports
off label use2,947 reports
dyspnoea2,302 reports
pneumonia2,076 reports
diarrhoea2,048 reports
sinusitis1,965 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Indications and Usage Uses: Temporaily relieves minor pains.

Dosage & Administration

Dosage and Administration Directions ■ Adults and children 2 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a i 2 hour period. Maximum 2 patches per day. Discard patch after single use. ■ Children under 2 years of age: Do not use, ask a doctor

Warnings

Warnings For external use only.

Frequently Asked Questions

What is Pain Relief Patch used for?

Pain Relief Patch contains Pain Relief Patch. It is a patch taken topical. Consult your doctor for specific uses.

Is Pain Relief Patch a controlled substance?

Pain Relief Patch is not classified as a controlled substance by the DEA.

What is the generic name for Pain Relief Patch?

The generic name for Pain Relief Patch is Pain Relief Patch. There are 11 other brand versions of Pain Relief Patch.

What is the NDC code for Pain Relief Patch 80 mg/1001?

The NDC (National Drug Code) for Pain Relief Patch 80 mg/1001 is 78691-141, listed by QUEST USA CORP..