Genuine First Aid Burn Cream

Manufacturer
GFA Production (Xiamen) Co., Ltd.
Effective date
2024-10-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:53:09

Label at a glance#

ProductGenuine First Aid Burn
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

First aid to help prevent infection and for the temporary relief of pain and itching associated with: minor cuts, scrapes and burns.

Dosage and administration

Clean affected area. Apply a small amount on area, not more than 3 times daily. May be covered with a sterile bandage.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Lidocaine HCL 0.5%

Purpose:

OTC - PURPOSE SECTION

First aid antiseptic, external analgesic.

Uses:

INDICATIONS & USAGE SECTION

First aid to help prevent infection and for the temporary relief of pain and itching associated with: minor cuts, scrapes and burns.

Warnings:

WARNINGS SECTION

For external use only.

Do not use:

OTC - DO NOT USE SECTION

in eyes, in large quantities, over raw blistered areas on deep puncture wounds, animal bites or serious burns, for more than one week.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested, contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Clean affected area. Apply a small amount on area, not more than 3 times daily. May be covered with a sterile bandage.

Other information:

SPL UNCLASSIFIED SECTION

Store at room temperature.

Inactive ingredient:

INACTIVE INGREDIENT SECTION

Peregal-O 2.5%

Glycerin monostearate 2.5%

Glycerol 5%

Purified water.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50814-005GENUINE FIRST AID BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [GFA PRODUCTION (XIAMEN) CO., LTD.]7Unmatched20241010_65d59097-2982-4530-8f47-9b25235d10bf.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50814-00550814-005-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2406fe59-6bad-4913-e063-6294a90a13e665d59097-2982-4530-8f47-9b25235d10bf2024-10-09WarningsExact identifier
spl id: 2406fe59-6bad-4913-e063-6294a90a13e6
spl set id: 65d59097-2982-4530-8f47-9b25235d10bf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.