Drugplain

Burn Gel .02 g/g

Lidocaine HCI · GEL · Trifecta Pharmaceuticals USA LLC

No Recall HistoryCurrently in Shortage
Plain English

Burn Gel is a gel containing lidocaine hci at .02 g/g, taken topical. Manufactured by Trifecta Pharmaceuticals USA LLC.

Key Facts

Brand Name
Burn Gel
Generic Name
Lidocaine HCI
NDC Code (Product)
69396-106
Manufacturer
Trifecta Pharmaceuticals USA LLC
Strength
.02 g/g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
09/27/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

infusion site pain682 reports
nausea473 reports
drug ineffective435 reports
infusion site erythema422 reports
headache415 reports
dyspnoea410 reports
diarrhoea400 reports
off label use400 reports
fatigue352 reports
pain331 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses: First aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with minor: Burns Cuts Sunburn Scrapes Minor Skin Irritation

Dosage & Administration

Directions: Adults and children 2 years of age & older: Clean the affected area. Apply a small amount of gel on the affected area 1 to 3 times daily. May be covered with a sterile bandage (let dry first). cover with adhesive bandage or sterile gauze if needed apply 1 to 3 times daily. Children under 2 years of age: ask a doctor

Warnings

Warnings For external use only Ask a doctor before use if you have: Deep or puncture wounds Animal bite Serious burns Do not use: In or near the eyes In large quantities or over large areas of the body On raw surfaces or blistered areas Stop use and ask a doctor if: Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding, ask a health care professional before use. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center immediately.

Frequently Asked Questions

What is Burn Gel used for?

Burn Gel contains Lidocaine HCI. It is a gel taken topical. Consult your doctor for specific uses.

Is Burn Gel a controlled substance?

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

What is the generic name for Burn Gel?

The generic name for Burn Gel is Lidocaine HCI. There are 11 other brand versions of Lidocaine HCI.

What is the NDC code for Burn Gel .02 g/g?

The NDC (National Drug Code) for Burn Gel .02 g/g is 69396-106, listed by Trifecta Pharmaceuticals USA LLC.