Drugplain

Capsaicin .035 g/100g

Capsaicin · PATCH · PHARMACURE LLC

10 Recalls on Record
Plain English

Capsaicin patches are applied directly to your skin to help relieve minor aches and pains, such as those from arthritis or muscle soreness. The patch works by temporarily desensitizing nerve endings in the treated area to reduce pain sensations.

Key Facts

Brand Name
Capsaicin
Generic Name
Capsaicin
NDC Code (Product)
79643-007
Manufacturer
PHARMACURE LLC
Strength
.035 g/100g
Dosage Form
PATCH
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
01/24/2025

Recall History

10 Recalls on Record
Class II05/16/2018

Ideaz Llc

CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.

TerminatedVoluntary: Firm initiated
Class II04/17/2024

ARG Laboratories, Inc.

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

OngoingVoluntary: Firm initiated
Class II10/24/2024

Unexo Life Sciences Private Limited

cGMP Deviations

TerminatedVoluntary: Firm initiated
Class II08/11/2023

AVKARE LLC

Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

TerminatedVoluntary: Firm initiated
Class II04/17/2024

ARG Laboratories, Inc.

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

OngoingVoluntary: Firm initiated
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 II04/17/2024

ARG Laboratories, Inc.

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

OngoingVoluntary: Firm initiated
Class II04/17/2024

ARG Laboratories, Inc.

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

OngoingVoluntary: Firm initiated
Class II01/27/2016

Bonita Pharmaceuticals, LLC

Marketed without an approved NDA/ANDA

TerminatedVoluntary: Firm initiated
Class II02/24/2023

Ecometics, Inc.

CGMP DEVIATIONS

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective213 reports
fatigue144 reports
off label use106 reports
weight increased97 reports
pain96 reports
insomnia89 reports
poor quality sleep75 reports
hypertension71 reports
cataract68 reports
impaired quality of life67 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Temporarily relieves minor aches and pains of muscles and joints due to: • simple backache • arthritis • strains • sprains

Dosage & Administration

Directions Adults and children 18 years of age and older: Apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application for best results. Apply 3 to 4 times daily. Children under 18 years : Ask a doctor

Warnings

Warnings For external use only Read all warnings and directions before use. Test first on small area of skin. Do not use • On wounds or damaged skin • If you are allergic to capsicum or chili peppers Whe n us ing this product • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days. • Avoid contact with the eyes, lips, nose and mucous membranes • Do not tightly wrap or bandage the treated area • Do not apply heat to the treated area immediately before or after use Stop use and as k a doctor if • Condition worsens or does not improve after regular use • Severe burning persists or blistering occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Frequently Asked Questions

What is Capsaicin used for?

Capsaicin patches are applied directly to your skin to help relieve minor aches and pains, such as those from arthritis or muscle soreness. The patch works by temporarily desensitizing nerve endings in the treated area to reduce pain sensations.

Is Capsaicin a controlled substance?

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

What is the generic name for Capsaicin?

The generic name for Capsaicin is Capsaicin. There are 10 other brand versions of Capsaicin.

What is the NDC code for Capsaicin .035 g/100g?

The NDC (National Drug Code) for Capsaicin .035 g/100g is 79643-007, listed by PHARMACURE LLC.