FDA.reportPublic FDA data

Antibacterial Lidocaine Wound Gel

Manufacturer
Water-Jel Technologies, LLC
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:30:48

Label at a glance#

ProductAntibacterial Lidocaine Wound Gel
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

clean the affected area adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a doctor may be covered with a sterile bandage if bandaged, let dry first

Label contents#

Full prescribing information#

Active ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Lidocaine Hydrochloride 2.00%

Purpose

OTC - PURPOSE SECTION

first aid antiseptic

external analgesic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection in minor cuts, scrapes and burns

For the temporary relief of pain associated with minor burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

in the eyes

over large areas of the body, particularly over raw surfaces or blistered areas

longer than a week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

deep or puncture wounds

animal bites

serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

the condition persists more than 7 days or gets worse

Condition clears up and occurs again within a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

clean the affected area

adults and children 2 years of age and older:

apply to affected area not more than 3 to 4 times daily

children under 2 years of age: consult a doctor

may be covered with a sterile bandage

if bandaged, let dry first

Other information

OTHER SAFETY INFORMATION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

caprylyl glycol, chlorphenesin, edetate disodium, glycerin, hydroxyethyl cellulose, phenoxyethanol, polysorbate 20, purified water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BZKLG1ASOBZKLG1ASO

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1431682benzalkonium chloride 0.13 % / lidocaine HCl 2 % Topical GelPSN3
1431682benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.02 MG/MG Topical GelSCD3
1431682benzalkonium chloride 0.13 % / lidocaine hydrochloride 2 % Topical GelSY3

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
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59898-950-01Antibacterial Lidocaine Wound Gel1 in 1 CARTONGEL13
59898-950-01Antibacterial Lidocaine Wound Gel14 mL in 1 TUBEGEL143
59898-950-02Antibacterial Lidocaine Wound Gel1 in 1 CARTONGEL13
59898-950-02Antibacterial Lidocaine Wound Gel28 mL in 1 TUBEGEL283

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59898-95059898-950-01, 59898-950-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLYL GLYCOL00YIU5438UIACT
EDETATE DISODIUM7FLD91C86KIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
CHLORPHENESINI670DAL4SZIACT

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
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWater-Jel Technologies, LLCef1a6100-7f78-1fdb-e053-2a95a90abf202025-12-31WarningsExact identifier
ndc (package): 59898-950-02
ndc (package): 59898-950-01
ndc (product): 59898-950
ndc11 (package): 59898095001
ndc11 (package): 59898095002
spl id: 474af77e-7568-d8f0-e063-6294a90a7fc9
spl set id: ef1a6100-7f78-1fdb-e053-2a95a90abf20

Reported adverse events (FAERS/openFDA)#

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