FDA.reportPublic FDA data

Amazon Lidocaine Patch Drug Facts

Manufacturer
Amazon.com Services LLC
Effective date
2021-03-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:47:57

Label at a glance#

Productbasic care lidocaine
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

For temporary relief of pain

Dosage and administration

Adults and children 12 years of age and over: • clean and dry affected area • remove film from patch and apply to the skin (see illustration) • apply 1 patch at a time to affected area, not more than 3 to 4 times daily • remove patch from the skin after at most 8 hours of application Children under 12 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you have ever had an allergic reaction to this product or any of its ingredients

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over:

  • clean and dry affected area
  • remove film from patch and apply to the skin (see illustration)
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • remove patch from the skin after at most 8 hours of application

Children under 12 years of age: consult a doctor

Other information

OTHER SAFETY INFORMATION

  • avoid storing product in direct sunlight
  • protect product from excessive moisture
  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, purified water, sodium polyacrylate, sodium polyacrylate starch, sorbitol solution, tartaric acid, urea

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Maximum Strength

Compare to Aspercreme® Lidocaine Patch XL

active ingredient

Lidocaine Patch

4% Lidocaine

Topical Anesthetic

Numbs Away Pain

Desensitizes Aggravated Nerves

Fast Acting

Non Irritating

Unscented

XL

3 PATCHES

4-23/32” x 7-7/8” (12 cm x 20 cm)

lidocaine patch image
lidocaine patch image

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72288-67172288-671-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
KAOLIN24H4NWX5COIACT
METHYLPARABENA2I8C7HI9TIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TARTARIC ACIDW4888I119HIACT
UREA8W8T17847WIACT

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
dd2a0d70-8d6b-4fd8-bc23-08729792cafd5555f73e-686d-4921-9b8d-4e6417c3c67d2024-11-14WarningsExact identifier
spl set id: 5555f73e-686d-4921-9b8d-4e6417c3c67d

Reported adverse events (FAERS/openFDA)#

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