ANTIBACTERIAL LIDOCAINE WOUND GEL- benzalkonium chloride, lidocaine hydrochloride gel 
Water-Jel Technologies, LLC

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Antibacterial Lidocaine Wound Gel

Active ingredients (in each gram)

Benzalkonium Chloride 0.13%

Lidocaine Hydrochloride 2.00%

Purpose

first aid antiseptic

external analgesic

Uses

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

For the temporary relief of pain associated with minor burns

Warnings

For external use only

Do not use

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

deep or puncture wounds

animal bites

serious burns

Stop use and ask a doctor if

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

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

Directions

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

Store at room temperature

Inactive ingredients

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

Principal Display Panel

Principal Display Label

ANTIBACTERIAL LIDOCAINE WOUND GEL 
benzalkonium chloride, lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-950
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Product Characteristics
Colorwhite (Colorless, clear translucent) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-950-011 in 1 CARTON10/28/2019
114 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:59898-950-021 in 1 CARTON10/28/2019
228 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/28/2019
Labeler - Water-Jel Technologies, LLC (155522589)

Revised: 1/2024
Document Id: 1005e593-a81f-40af-e063-6294a90aa46d
Set id: ef1a6100-7f78-1fdb-e053-2a95a90abf20
Version: 2
Effective Time: 20240128
 
Water-Jel Technologies, LLC