FIRST AID BURN

LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE TOPICAL HUMAN OTC DRUG

FIRST AID BURN is an FDA drug label for the active ingredient LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE manufactured by 4 Visions LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260430.

Generic name
LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE
Manufacturer
4 Visions LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
87251-009
Application
M017
Label effective
20260430

About this product

FIRST AID BURN is an FDA-registered drug product whose active ingredient is LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE. It is labelled by 4 Visions LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 87251-009, application M017, label effective 20260430. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE are most often described in connection with: temporary relief, itching associated, sunburn minor, burns insect, skin irritation, cuts scrapes. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredients Lidocaine HCL 0.5% Topical Analgesic Benzalkonium Chloride 0.13% Topical Antiseptic

Indications & Usage

Uses For temporary relief of pain and itching associated with: Sunburn Minor burns, Insect bites, Minor skin irritation, 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.

Recall and safety notices

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0244-2023 Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hydrochloride 0.5%), 0.9 g (0.03 oz) packets packaged in boxes of 10, Treatment for Burns, Made in China for Adventure Ready Brands, 944 Industrial Park Rd., Littleton, NH 03561, NDC 90107-0210, Product # 9999-1515 GFA Production Xiamen Co. Ltd. Class I Terminated 20230208

Frequently asked questions

What is FIRST AID BURN used for?
Uses For temporary relief of pain and itching associated with: Sunburn Minor burns, Insect bites, Minor skin irritation, Cuts Scrapes

Who makes FIRST AID BURN?
4 Visions LLC is the labeler of record for FIRST AID BURN.

What form does FIRST AID BURN come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is FIRST AID BURN prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has FIRST AID BURN been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.