FDA.reportPublic FDA data

Lidocaine HCl 4%

Manufacturer
AvPAK | Denison Pharmaceuticals
Effective date
2021-06-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:42:55

Label at a glance#

ProductLidocaine HCl 4%
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

temporarily relieves pain and itching due to: minor cuts minor scrapes sunburn minor skin irritations minor burns insect bites

Dosage and administration

Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily. Children under 2 years of age: Consult a doctor.

Storage and handling

Store at USP controlled room temperature 20-25 °C (68-77 °F).

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4% w/w

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to:

  • minor cuts
  • minor scrapes
  • sunburn
  • minor skin irritations
  • minor burns
  • insect bites

WARNINGS

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask doctor if

OTC - ASK DOCTOR SECTION

  • Allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years of age: Consult a doctor.

Other Information

STORAGE AND HANDLING SECTION

Store at USP controlled room temperature 20-25 °C (68-77 °F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, carbomer 940, BHT, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopherol acetate, trolamine, water

Questions or comments?

1-855-361-3993

Manufactured for:

AvKARE

Pulaski, TN 38478

Lidocaine HCl 4% 10 x 5 g Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-490-30GM - Gram50268-4908c77d7a4-2fc5-4744-8572-b4669d2ff2a112021-09-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50268-49050268-490-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f1feda78-c7d3-45ea-e053-2995a90a7df3270ed9fb-cbfe-4fad-a2ab-2cef154e1a602023-01-11WarningsExact identifier
spl set id: 270ed9fb-cbfe-4fad-a2ab-2cef154e1a60

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.