Lidocaine 5% Cream

Manufacturer
AvKARE
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:17:09

Label at a glance#

ProductLidocaine
Active ingredientLIDOCAINE
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 degC (68-77 deg.F).

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% 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 degC (68-77 deg.F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ceteareth-6, ceteareth-25, cetyl alcohol, methylparaben, paraffin, propylene glycol, propylparaben, purified water, stearyl alcohol, and xanthan gum.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42291-400-30
Lidocaine
5%
Cream
Topical Anesthetic Cream
Net Wt. 30 gm

Drug Facts
Active ingredient Purpose
Lidocaine 5% w/w
............................Topical anesthetic
Uses
Temporarily relieves pain and
itching due to:
❚ minor cuts ❚ minor scrapes
❚ sunburn ❚ minor burns
❚ minor skin irritations
❚ insect bites
Warnings
For external use only.
When using this product
❚ do not use in or near the eyes
❚ do not use in large quantities,
particularly over raw surfaces
or blistered ares
Stop use and ask a doctor if
❚ 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.
If swallowed, get medical help or
contact a Poison Control Center
right away
Directions
❚ 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 physician
Other Information
❚ Store at USP controlled room
temperature 20°-25°C
(68° - 77°F)
Inactive Ingredients
Ceteareth-6, ceteareth-25, cetyl
alcohol, methylparaben, paraffin,
propylene glycol, propylparaben,
purified water, stearyl alcohol,
xanthan gum.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
AV 03/18 Rev: 03/18

Label 1Label 1

Label 2Label 2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-400-30GM - Gram42291-40026ff6ba5-1909-48e8-b828-8608db44734e12018-08-13

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
42291-40042291-400-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
f16033c9-3f6a-be6f-e053-2a95a90a961770b9eb31-70f2-4baa-e053-2a91aa0aa7862023-01-03WarningsExact identifier
spl set id: 70b9eb31-70f2-4baa-e053-2a91aa0aa786

Reported adverse events (FAERS/openFDA)#

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