FDA.reportPublic FDA data

First Aid Antiseptic Pain Relieving Cream

Manufacturer
Hubei Fanjian Medical Product Co.,Ltd
Effective date
2026-05-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:59:13

Label at a glance#

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

Indications and uses

first aid to help decrease the risk of infection in minor  • cuts • scrapes • burns • for the temporary relief of pain

Dosage and administration

• adults and children two years of age and older • clean the affected area apply a small amount of this product on the area 1 to 3 times daily • may be covered with a sterile bandage • children under 2 years of age: consult a doctor

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 reliever

Uses

INDICATIONS & USAGE SECTION

first aid to help decrease the risk of infection in minor 

• cuts • scrapes • burns • for the temporary relief of pain

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, particularly over raw surfaces or blistered areas

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• deep or puncture wounds • serious burns • animal bites

Stop use and ask a doctor if 

OTC - STOP USE SECTION

• condition persists or gets worse

• you need to use this product for more than 1 week

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

• adults and children two years of age and older

• clean the affected area apply a small amount of this product on the area 1 to 3 times daily

• may be covered with a sterile bandage

• children under 2 years of age: consult a doctor

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

LabelLabel

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
83165-004-00First Aid Antiseptic Pain Relieving Cream0.9 g in 1 PATCHLIQUID0.93
83165-004-00First Aid Antiseptic Pain Relieving Cream1 in 1 PACKAGELIQUID13

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
83165-00483165-004-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL MONOSTEARATE230OU9XXE4IACT
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
First Aid Antiseptic Pain Relieving CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEHubei Fanjian Medical Product Co.,Ltdf44aa5a9-45e2-b890-e053-2a95a90a421b2026-05-28WarningsExact identifier
ndc (package): 83165-004-00
ndc (product): 83165-004
ndc11 (package): 83165000400
spl id: 52e2d298-ef83-a120-e063-6394a90a2fc6
spl set id: f44aa5a9-45e2-b890-e053-2a95a90a421b

Reported adverse events (FAERS/openFDA)#

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