ANTIBACTERIAL LIDOCAINE WOUND GEL- benzalkonium chloride, lidocaine hydrochloride gel

Antibacterial Lidocaine Wound Gel by

Drug Labeling and Warnings

Antibacterial Lidocaine Wound Gel by is a Otc medication manufactured, distributed, or labeled by Water-Jel Technologies, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL LIDOCAINE WOUND GEL 
benzalkonium chloride, lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59898-950
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2 g  in 100 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (Colorless, clear translucent)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59898-950-01	1 in 1 CARTON	10/28/2019
1		14 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 59898-950-02	1 in 1 CARTON	10/28/2019
2		28 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/28/2019

Labeler - Water-Jel Technologies, LLC (155522589)