Drugplain

First Aid Burn .13 g/100g

Benzalkonium Chloride, Lidocaine Hydrochloride · CREAM · Water-Jel Technologies

1 Recall on Record
Plain English

First Aid Burn is a cream containing benzalkonium chloride, lidocaine hydrochloride at .13 g/100g, taken topical. Manufactured by Water-Jel Technologies.

Key Facts

Brand Name
First Aid Burn
Generic Name
Benzalkonium Chloride, Lidocaine Hydrochloride
NDC Code (Product)
59898-902
Manufacturer
Water-Jel Technologies
Strength
.13 g/100g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
part348
Marketing Start
04/20/2010

Recall History

1 Recall 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

Side Effects Reported to FDA

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

drug ineffective3,898 reports
pain3,233 reports
fatigue3,012 reports
nausea2,990 reports
headache2,782 reports
off label use2,560 reports
dyspnoea2,144 reports
pneumonia1,971 reports
sinusitis1,928 reports
diarrhoea1,924 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 First Aid Burn used for?

First Aid Burn contains Benzalkonium Chloride, Lidocaine Hydrochloride. It is a cream taken topical. Consult your doctor for specific uses.

Is First Aid Burn a controlled substance?

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

What is the generic name for First Aid Burn?

The generic name for First Aid Burn is Benzalkonium Chloride, Lidocaine Hydrochloride. There are 11 other brand versions of Benzalkonium Chloride, Lidocaine Hydrochloride.

What is the NDC code for First Aid Burn .13 g/100g?

The NDC (National Drug Code) for First Aid Burn .13 g/100g is 59898-902, listed by Water-Jel Technologies.