BLUE-EMU LIDOCAINE DRY- lidocaine patch

Blue-Emu Lidocaine Dry by

Drug Labeling and Warnings

Blue-Emu Lidocaine Dry by is a Otc medication manufactured, distributed, or labeled by NFI, LLC, ProSolus, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine 4%

Purpose

Topical anesthetic

Use

For the temporary relief of pain.

Warnings

For external use only.

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

• 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

• 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

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

Keep out of reach of children and pets.

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

Directions

Adults and children over 12 years of age:

Apply patch to affected area every 8 to 12 hours.

Children 12 years or younger:

Consult a physician before use.

Instructions for 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 relief until several minutes or hours after applying a patch
• do not use other local anesthetic products in addition to Lidocare

Storage Information

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

Inactive Ingredients

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

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"

INGREDIENTS AND APPEARANCE

BLUE-EMU LIDOCAINE DRY 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69993-425
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)	Lidocaine	22 mg

Inactive Ingredients
Ingredient Name	Strength
Isopropyl Alcohol (UNII: ND2M416302)
Heptane (UNII: 456148SDMJ)
Emu Oil (UNII: 344821WD61)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69993-425-03	3 in 1 CARTON	04/08/2020
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/08/2020

Labeler - NFI, LLC (121681919)

Establishment
Name	Address	ID/FEI	Business Operations
ProSolus, Inc.		969793079	MANUFACTURE(69993-425)