FDA.reportPublic FDA data

Genuine First Aid First Aid Antiseptic Pain Relieving Cream

Manufacturer
GFA Production (Xiamen) Co., Ltd.
Effective date
2024-10-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:25:21

Label at a glance#

ProductGenuine First Aid First Aid Antiseptic Pain Relieving Cream
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

First aid to help prevent infection in minor cuts, scrapes, and burns. For the temporary relief of pain and itching associated with minorburns, minorcuts, and scrapes.

Dosage and administration

Clean the affected area. Adults and children 2 years of age and older. Apply a small amount of this product to affected area not more than 3 times daily Children under 2 years of age:consult a doctor May be covered with a sterile bandage.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Pain relieving cream

Uses

INDICATIONS & USAGE SECTION

  • First aid to help prevent infection in minor cuts, scrapes, and burns.
  • For the temporary relief of pain and itching associated with minorburns, minorcuts, and scrapes.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in the eyes.
  • over large areas of the body
  • in large quantities
  • over raw surfaces or listed areas
  • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • animals bites
  • deep or puncture wounds
  • serious burns.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • the condition persists or gets worse
  • symptoms persists for more than 7 days or clearup and occurs again with in a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area.
  • Adults and children 2 years of age and older. Apply a small amount of this product to affected area not more than 3 times daily
  • Children under 2 years of age:consult a doctor
  • May be covered with a sterile bandage.

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin monostearate, glycerol, purified water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle6Bottle6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN3
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD3
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50814-059-01Genuine First Aid First Aid Antiseptic Pain Relieving Cream0.9 g in 1 PACKAGECREAM0.93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50814-059GENUINE FIRST AID FIRST AID ANTISEPTIC PAIN RELIEVING CREAM (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [GFA PRODUCTION (XIAMEN) CO., LTD.]3Current NDC, Legacy NDC, 1 package rows20241016_af08c8f7-8761-ee3f-e053-2995a90a9677.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50814-05950814-059-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
Genuine First Aid First Aid Antiseptic Pain Relieving CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.af08c8f7-8761-ee3f-e053-2995a90a96772024-10-15WarningsExact identifier
ndc (package): 50814-059-01
ndc (product): 50814-059
ndc11 (package): 50814005901
spl id: 247ed23b-986a-29de-e063-6394a90a33bd
spl set id: af08c8f7-8761-ee3f-e053-2995a90a9677

Reported adverse events (FAERS/openFDA)#

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