ANTIBACTERIAL LIDOCAINE WOUND GEL- benzalkonium chloride, lidocaine hydrochloride gel 
ASO LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Antibacterial Lidocaine Wound Gel

Active ingredient (in each gram)

Benzalkonium Chloride 0.13%
Lidocaine Hydrochloride 2.00%

Purpose

first aid antiseptic
external analgesic

Uses

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

Other information

Store at room temperature

Inactive ingredients

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

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

label

ANTIBACTERIAL LIDOCAINE WOUND GEL 
benzalkonium chloride, lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51142-652(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
WATER (UNII: 059QF0KO0R)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Product Characteristics
Colorwhite (colorless, clear translucent) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51142-652-141 in 1 CARTON10/28/2019
114 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:51142-652-281 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 not finalpart333A10/28/2019
Labeler - ASO LLC (152793493)

Revised: 12/2022
Document Id: eff7293a-fb6f-0c0a-e053-2995a90a69fd
Set id: cb9505b7-222d-3a24-e053-2a95a90a0b64
Version: 2
Effective Time: 20221216
 
ASO LLC