Lidocaine Back / Shoulder Patch

Drug Facts

Composition & Product

Active Ingredients

Lidocaine (4 g)

Inactive Ingredients

Crospovidone, Unspecified 3-(l-menthoxy)-2-methylpropane-1,2-diol Vanillyl Butyl Ether

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-05-01

Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

Use

For the temporary relief of pain.

Section 42229-5

DISTRIBUTED BY:

NFI CONSUMER PRODUCTS

501 Fifth Street

Bristol, TN 37620

TOLL FREE: 800-432-9334

WWW.LIDOCARE.COM

Warnings

For external use only.

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.

Active Ingredients

Lidocaine 4%

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.

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.

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
•
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 Poison Control Center right away.

Principal Display Panel – 3 Patch Carton Label

FROM THE MAKERS OF BLUE-EMU^®

Lidocare™

4% LIDOCAINE

PAIN RELIEF

PATCH

BACK/SHOULDER

PATENT PENDING

PRESSURE ADHESIVE

PATCH

PATCH SIZE

2.5” x 6”

MADE IN

THE USA

ULTRA-FLEXIBLE

ODOR-FREE

FOR THE TEMPORARY RELIEF OF PAIN

3 PATCHES

1 PATCH PER POUCH

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 if you are allergic to lidocaine or any of the inactive ingredients listed below.

Structured Label Content

Use

For the temporary relief of pain.

Section 42229-5 (42229-5)

DISTRIBUTED BY:

NFI CONSUMER PRODUCTS

501 Fifth Street

Bristol, TN 37620

TOLL FREE: 800-432-9334

WWW.LIDOCARE.COM

Purpose

Topical anesthetic

Warnings

For external use only.

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.

Active Ingredients

Lidocaine 4%

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.

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.

When Using This Product (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 (Stop use and ask 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, (If pregnant or breast feeding,)

ask a health professional before use.

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

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

Principal Display Panel – 3 Patch Carton Label (PRINCIPAL DISPLAY PANEL – 3 Patch Carton Label)

FROM THE MAKERS OF BLUE-EMU^®

Lidocare™

4% LIDOCAINE

PAIN RELIEF

PATCH

BACK/SHOULDER

PATENT PENDING

PRESSURE ADHESIVE

PATCH

PATCH SIZE

2.5” x 6”

MADE IN

THE USA

ULTRA-FLEXIBLE

ODOR-FREE

FOR THE TEMPORARY RELIEF OF PAIN

3 PATCHES

1 PATCH PER POUCH

Do Not Use If Pouch Is Damaged Or Opened. Do Not Use (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 if you are allergic to lidocaine or any of the inactive ingredients listed below.

Advanced Ingredient Data

[{"name": "LIDOCAINE", "unii": "98PI200987", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "CROSPOVIDONE, UNSPECIFIED", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "3-(L-MENTHOXY)-2-METHYLPROPANE-1,2-DIOL", "unii": "649M1Y2P72", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VANILLYL BUTYL ETHER", "unii": "S2ULN37C9R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "For the temporary relief of pain.", "42229-5": "DISTRIBUTED BY: NFI CONSUMER PRODUCTS 501 Fifth Street Bristol, TN 37620 TOLL FREE: 800-432-9334 WWW.LIDOCARE.COM", "Purpose": "Topical anesthetic", "Warnings": "For external use only.", "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.", "Active Ingredients": "Lidocaine 4%", "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. ", "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.", "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 • 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 Poison Control Center right away.", "PRINCIPAL DISPLAY PANEL – 3 Patch Carton Label": "FROM THE MAKERS OF BLUE-EMU ® Lidocare™ 4% LIDOCAINE PAIN RELIEF PATCH BACK/SHOULDER PATENT PENDING PRESSURE ADHESIVE PATCH PATCH SIZE 2.5” x 6” MADE IN THE USA ULTRA-FLEXIBLE ODOR-FREE FOR THE TEMPORARY RELIEF OF PAIN 3 PATCHES 1 PATCH PER POUCH", "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 if you are allergic to lidocaine or any of the inactive ingredients listed below."}

Lidocaine Back / Shoulder Patch

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information