Drugplain

Burn Relief 20 g/L

Lidocaine HCI 2.0% · SPRAY · Trifecta Pharmaceuticals USA, LLC.

1 Recall on RecordCurrently in Shortage
Plain English

Burn Relief is a spray containing lidocaine hci 2.0% at 20 g/L, taken topical. Manufactured by Trifecta Pharmaceuticals USA, LLC..

Key Facts

Brand Name
Burn Relief
Generic Name
Lidocaine HCI 2.0%
NDC Code (Product)
69396-107
Manufacturer
Trifecta Pharmaceuticals USA, LLC.
Strength
20 g/L
Dosage Form
SPRAY
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
07/28/2022

Recall History

1 Recall on Record
Class II01/16/2014

The Mentholatum Co.

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective4,331 reports
pain3,544 reports
nausea3,464 reports
fatigue3,348 reports
headache3,199 reports
off label use2,943 reports
dyspnoea2,547 reports
diarrhoea2,292 reports
pneumonia2,134 reports
vomiting2,089 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses First Aid to help prevent infection and for the temporary relief of pain or discomfort in minor cuts, scrapes and burns.

Dosage & Administration

Directions Adults and children 2 years of age and older: Clean the affected area and dry thoroughly. Apply a small amount of this product , an mount equal to the surgace area of the tip of a finger) on the area 1 to 3 times daily May be covered with a sterile bandage Children under 2 years old: ask a doctor

Warnings

Warnings For external Use Only

Frequently Asked Questions

What is Burn Relief used for?

Burn Relief contains Lidocaine HCI 2.0%. It is a spray taken topical. Consult your doctor for specific uses.

Is Burn Relief a controlled substance?

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

What is the generic name for Burn Relief?

The generic name for Burn Relief is Lidocaine HCI 2.0%. There are no other listed brand versions of Lidocaine HCI 2.0%.

What is the NDC code for Burn Relief 20 g/L?

The NDC (National Drug Code) for Burn Relief 20 g/L is 69396-107, listed by Trifecta Pharmaceuticals USA, LLC..

Product NDC

69396-107

Package NDC

69396-107-02

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

Data from openFDA · Public domain (CC0 1.0)