Drugplain

Burn Cream .0013 g/g

Benzalkonium Chloride, Lidocaine HCI · CREAM · Trifecta Pharmaceuticals USA LLC

10 Recalls on Record
Plain English

Burn Cream is a cream containing benzalkonium chloride, lidocaine hci at .0013 g/g, taken topical. Manufactured by Trifecta Pharmaceuticals USA LLC.

Key Facts

Brand Name
Burn Cream
Generic Name
Benzalkonium Chloride, Lidocaine HCI
NDC Code (Product)
69396-146
Manufacturer
Trifecta Pharmaceuticals USA LLC
Strength
.0013 g/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M003
Marketing Start
03/06/2024

Recall History

10 Recalls on Record
Class I12/23/2022

GFA Production Xiamen Co. Ltd.

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

TerminatedVoluntary: Firm initiated
Class I12/23/2022

GFA Production Xiamen Co. Ltd.

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

TerminatedVoluntary: Firm initiated
Class I12/23/2022

GFA Production Xiamen Co. Ltd.

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

TerminatedVoluntary: Firm initiated
Class I12/23/2022

GFA Production Xiamen Co. Ltd.

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

TerminatedVoluntary: Firm initiated
Class I12/23/2022

GFA Production Xiamen Co. Ltd.

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

TerminatedVoluntary: Firm initiated
Class I12/23/2022

GFA Production Xiamen Co. Ltd.

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

TerminatedVoluntary: Firm initiated
Class I12/23/2022

GFA Production Xiamen Co. Ltd.

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

TerminatedVoluntary: Firm initiated
Class I12/23/2022

GFA Production Xiamen Co. Ltd.

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

TerminatedVoluntary: Firm initiated
Class I12/23/2022

GFA Production Xiamen Co. Ltd.

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

TerminatedVoluntary: Firm initiated
Class I12/23/2022

GFA Production Xiamen Co. Ltd.

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

disease progression1 reports
drug ineffective for unapproved indication1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use(s) For the temporary relief of pain and itching associated with: • Sunburn • Minor burns • Insect bites • Cuts • Scrapes

Dosage & Administration

Directions Adults and children 2 years and over: • Clean the affected area • Apply a small amount of this product on the area 3 to 4 times daily • May be covered with a sterile bandage Children under 2 years: • Consult a doctor

Warnings

Warnings For External Use Only. Do not use • In the eyes • Over large areas of the body or on deep puncture wounds, animal bites, or serious burns • In large quantities, particularly over raw surfaces or blistered areas Stop use and ask a doctor if • The condition gets worse • Condition clears up and recurs within a few days • Condition persists for more than 7 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 (1-800-222-1222) right away.

Frequently Asked Questions

What is Burn Cream used for?

Burn Cream contains Benzalkonium Chloride, Lidocaine HCI. It is a cream taken topical. Consult your doctor for specific uses.

Is Burn Cream a controlled substance?

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

What is the generic name for Burn Cream?

The generic name for Burn Cream is Benzalkonium Chloride, Lidocaine HCI. There are 2 other brand versions of Benzalkonium Chloride, Lidocaine HCI.

What is the NDC code for Burn Cream .0013 g/g?

The NDC (National Drug Code) for Burn Cream .0013 g/g is 69396-146, listed by Trifecta Pharmaceuticals USA LLC.

Product NDC

69396-146

Package NDC

69396-146-10

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

Data from openFDA · Public domain (CC0 1.0)