Antibiotic Free Wound Gel and Pain Relief: Package Insert and Label Information

ANTIBIOTIC FREE WOUND GEL AND PAIN RELIEF- 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

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

Antibacterial

Lidocaine Wound Gel

LIDOCAINE HYDROCHLORIDE, 2%
BENZALKONIUM CHLORIDE, 0.13%
Antibacterial Gel with Pain Relief Helps Prevent Infection

  • Antibiotic Free
  • For treating minor cuts, scrapes & burns
  • Water-based clear hydrogel
  • Helps reduce scarring

NET WT 0.5 OZ (14 g)

Label
(click image for full-size original)
ANTIBIOTIC FREE WOUND GEL AND PAIN RELIEF
benzalkonium chloride and lidocaine hydrochloride gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51142-352
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
EDETATE DISODIUM
POLYSORBATE 20
CAPRYLYL GLYCOL
PHENOXYETHANOL
GLYCERIN
WATER
CHLORPHENESIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51142-352-32 1 TUBE in 1 CARTON contains a TUBE
1 28 mL in 1 TUBE This package is contained within the CARTON (51142-352-32)
2 NDC:51142-352-14 1 TUBE in 1 CARTON contains a TUBE
2 14 mL in 1 TUBE This package is contained within the CARTON (51142-352-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/21/2017 09/01/2022
Labeler — ASO LLC (152793493)

Revised: 09/2021 ASO LLC

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