FDA.reportPublic FDA data

Antibacterial Lidocaine Wound Gel

Manufacturer
ASO LLC
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:34:33

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 ingredient (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

CARE SCIENCE

Antibacterial

Lidocaine Wound Gel

Lidocaine Hydrochloride 2%

Benzalkonium Chloride 0.13%

Pain Relief

Antibacterial gel helps prevent infection

For treating minor cuts, scrapes and burns

Helps reduce scarring

Water-based clear hydrogel

Antibiotic free

labellabel

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
51142-652-14Antibacterial Lidocaine Wound Gel1 in 1 CARTONGEL13
51142-652-14Antibacterial Lidocaine Wound Gel14 mL in 1 TUBEGEL143
51142-652-28Antibacterial Lidocaine Wound Gel1 in 1 CARTONGEL13
51142-652-28Antibacterial Lidocaine Wound Gel28 mL in 1 TUBEGEL283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51142-652ANTIBACTERIAL LIDOCAINE WOUND GEL (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) GEL [ASO LLC]3Current NDC, Legacy NDC, 4 package rows20241107_cb9505b7-222d-3a24-e053-2a95a90a0b64.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51142-65251142-652-14, 51142-652-28
59898-950

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
WATER059QF0KO0RIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
CAPRYLYL GLYCOL00YIU5438UIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
CHLORPHENESINI670DAL4SZIACT
POLYSORBATE 207T1F30V5YHIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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 · 2 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 (product): 59898-950
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEASO LLCcb9505b7-222d-3a24-e053-2a95a90a0b642024-11-05WarningsExact identifier
ndc (package): 51142-652-28
ndc (package): 51142-652-14
ndc (product): 51142-652
ndc11 (package): 51142065214
ndc11 (package): 51142065228
spl id: 262f971a-aa6f-8cd4-e063-6394a90a40b0
spl set id: cb9505b7-222d-3a24-e053-2a95a90a0b64

Reported adverse events (FAERS/openFDA)#

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