Antibacterial Lidocaine Wound Gel: Package Insert and Label Information

ANTIBACTERIAL LIDOCAINE WOUND GEL- lidocaine hydrochloride and benzalkonium chloride 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.

Active ingredient (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

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
(click image for full-size original)
ANTIBACTERIAL LIDOCAINE WOUND GEL
benzalkonium chloride, lidocaine hydrochloride gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51142-652
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2 g in 100 mL
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
HYDROXYETHYL CELLULOSE, UNSPECIFIED
CAPRYLYL GLYCOL
EDETATE DISODIUM (EDETIC ACID)
GLYCERIN
CHLORPHENESIN
POLYSORBATE 20
PHENOXYETHANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51142-652-14 1 TUBE in 1 CARTON contains a TUBE
1 14 mL in 1 TUBE This package is contained within the CARTON (51142-652-14)
2 NDC:51142-652-28 1 TUBE in 1 CARTON contains a TUBE
2 28 mL in 1 TUBE This package is contained within the CARTON (51142-652-28)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 10/28/2019
Labeler — ASO LLC (152793493)

Revised: 09/2021 ASO LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.