FDA.reportPublic FDA data

Blue-Emu ® Lidocaine Dry-Patch

Manufacturer
NFI, LLC | ProSolus, Inc.
Effective date
2023-05-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:31:42

Label at a glance#

ProductBlue-Emu Lidocaine Dry
Active ingredientLidocaine
Label structure9 sections

Dosage and administration

Apply patch to affected area every 8 to 12 hours. Consult a physician before use. • clean and dry affected area • cut open pouch and remove the patch • remove clear protective liner from the patch • apply to affected area no more than three (3) times per day • leave in place for up to 8 but no more than 12 hours • wash hands thoroughly after applying or removing patch • some individuals may not experience pain rel...

Storage and handling

• protect from freezing and excessive heat • store at 68°-77°F (20°-25°C).

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of pain.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use if pouch is damaged or opened. Do not use

  • on large areas of the body or on cut, irritated skin
  • on open wounds or sensitive skin
  • for more than one week without consulting a doctor
  • do not use more than one patch at a time
  • do not use if you are allergic to lidocaine or any of the inactive ingredients listed below.

When using this product

OTC - WHEN USING SECTION

  • use only as directed. Read and follow all directions and warnings on this package.
  • do not allow contact with the eyes
  • do not bandage or apply local heat (such as heating pads) to the area of use
  • do not reuse patch.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • rash, itching or skin irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets.

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years of age:

SPL UNCLASSIFIED SECTION

Apply patch to affected area every 8 to 12 hours.

Children 12 years or younger:

SPL UNCLASSIFIED SECTION

Consult a physician before use.

Instructions for Use

SPL UNCLASSIFIED SECTION

  • clean and dry affected area
  • cut open pouch and remove the patch
  • remove clear protective liner from the patch
  • apply to affected area no more than three (3) times per day
  • leave in place for up to 8 but no more than 12 hours
  • wash hands thoroughly after applying or removing patch
  • some individuals may not experience pain relief until several minutes or hours after applying a patch
  • do not use other local anesthetic products in addition to Lidocare

Storage Information

STORAGE AND HANDLING SECTION

  • protect from freezing and excessive heat
  • store at 68°-77°F (20°-25°C).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Crospovidone, menthoxypropanediol, non-woven backing fabric, polyester film, non-latex rubber based adhesive, vanillyl butyl ether.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
NFI CONSUMER PRODUCTS
501 Fifth Street • Bristol, TN 37620
Toll Free: 800-432-9334

PRINCIPAL DISPLAY PANEL - 3 Patch Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RELIEF YOU CAN WEAR™
 
BLUE-EMU®
 
No Mess!
Odor Free
+ Emu Oil
 
4% Lidocaine
Dry-Patch
 
AMERICA'S
#1
ODOR
FREE
EMU OIL FORMULA
 
3 PATCHES
2.5"X 6"

Lidocaine-01
Lidocaine-01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69993-425-032024-12-23C16284748780-11030e365-239a-111a-e063-dadaa90a10e2Blue-Emu ® Lidocaine Dry-Patch
69993-425-032024-07-30C16284748780-11030e365-239a-111a-e063-dadaa90a10e2Blue-Emu ® Lidocaine Dry-Patch
69993-425-032024-01-30C16284748780-11030e365-239a-111a-e063-dadaa90a10e2Blue-Emu ® Lidocaine Dry-Patch

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69993-42569993-425-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Lidocaine98PI200987ACTIB
Isopropyl AlcoholND2M416302IACT
Heptane456148SDMJIACT
Emu Oil344821WD61IACT

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
71cd72be-ad71-43f2-8bd7-df2182c271d03aa15458-30c2-4a63-9c9b-b65e8fe3e5de2024-12-09WarningsExact identifier
spl set id: 3aa15458-30c2-4a63-9c9b-b65e8fe3e5de

Reported adverse events (FAERS/openFDA)#

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