LIDOCARE 03- 4% lidocaine patch patch

Lidocare by

Drug Labeling and Warnings

Lidocare by is a Otc medication manufactured, distributed, or labeled by Kingsway Pharmaceuticals dba NFI, LLC, ProSolus, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Uses

For the temporary relief of pain.

Warnings

For external use only

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 doctor if

• condition worsens
• rash, itching or skin irritation develops
• symptons 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 Poison Control Center right away.

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 patch 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 patch
• do not use other anesthetic products in addition to Lidocare

Storage Information

• protect from freezing or 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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCARE  03
4% lidocaine patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69993-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
3-(L-MENTHOXY)-2-METHYLPROPANE-1,2-DIOL (UNII: 649M1Y2P72)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69993-400-03	3 in 1 CARTON	05/01/2016
1		1 in 1 PATCH; 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	05/01/2016

Labeler - Nutrition & Fitness, Inc., DBA NFI Consumer Products, Inc. (016785052)