Drugplain

Burn Cream 1.3 mg/g

Benzalkonium Chloride, Lidocaine Hydrochloride · CREAM · Total Resources International

10 Recalls on Record
Plain English

Burn Cream is a cream containing benzalkonium chloride, lidocaine hydrochloride at 1.3 mg/g, taken topical. Manufactured by Total Resources International.

Key Facts

Brand Name
Burn Cream
Generic Name
Benzalkonium Chloride, Lidocaine Hydrochloride
NDC Code (Product)
55550-902
Manufacturer
Total Resources International
Strength
1.3 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M003
Marketing Start
01/14/2020

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 Hydrochloride. 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 Hydrochloride. There are 12 other brand versions of Benzalkonium Chloride, Lidocaine Hydrochloride.

What is the NDC code for Burn Cream 1.3 mg/g?

The NDC (National Drug Code) for Burn Cream 1.3 mg/g is 55550-902, listed by Total Resources International.