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BENZALKONIUM CHLORIDE, LIDOCAINE
Orazen Inc · TOPICAL

Product NDC: 71927-019

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameBENZALKONIUM CHLORIDE, LIDOCAINE
Labeler / manufacturerOrazen Inc
RouteTOPICAL
Drug classDrug class not supplied in source label
Product NDC71927-019
Label effective date2026-09-05

Official product label reference

Medi-First — Orazen Inc

This page contains 11 source sections for BENZALKONIUM CHLORIDE, LIDOCAINE, topical route. Label set f508434f-5948-7134-e053-2a95a90a03d7, version 3.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Uses for the temporary relief of pain associated with minor burns helps protect against harmful bacteria

Purpose

Purpose First aid antiseptic Topical analgesic
Dosage and administration — label text
Directions Adults and children 2 years and over: clean the affected area, apply a small amount not more than 3 to 4 times daily Children under 2 years: do not use, consult a doctor
Warnings
Warnings For external use only.
Active ingredient
Active ingredients Benzalkonium Chloride 0.13% Lidocaine HCI 0.5%
Do not use
Do not use in the eyes in large quantities over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns for more than one week unless directed by a doctor
When to stop use and seek help
Stop use and ask a doctor if the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Child safety
Keep out of reach of children. If ingested, get medical help or contact a Poison Control Center right away.
Other safety information
Other information store at room temperature (do not freeze) tamper evident sealed packets do not use any opened or torn packets
Inactive ingredient
Inactive ingredients aloe barbadensis leaf juice, cetearyl alcohol,disodium EDTA, ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, maltodextrin, propylene glycol, purified water, palmitic acid, PEG-100 stearate,phenoxyethanol, stearic acid, sodium hydroxide
Questions
Questions or comments? 800-634-7680

Official sources and product identifiers

Substances listed: LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE

RxNorm identifiers: 1012100

Package NDC codes

71927-019-01, 71927-019-02

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.