Lidocore (single Unit Patch)

Lidocore (single Unit Patch)
SPL v3
SPL
SPL Set ID 161f5745-fec1-4ca3-be42-512f6d3e7fee
Route
TOPICAL
Published
Effective Date 2024-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Edetate Disodium Glycerin Kaolin Methylparaben Polysorbate 80 Propylene Glycol Polyacrylic Acid (450000 Mw) Povidone K90 Propylparaben Sodium Polyacrylate (2500000 Mw) Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Indications and Usage

Uses: For temporary relief of pain.

Purpose

Topical anesthetic

Dosage and Administration

Directions: Adults, or children over the age of 12: 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-hour application. Children under 12 years of age: Consult a doctor.

Description

Lidocaine 4%

Section 50565-1

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and consult a doctor if:

  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering.
  • Conditions worsen
  • Symptoms persist more than 7 days
  • Symptoms clear up and occur again within a few days.
Section 50567-7

When using this product:

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly.
Section 50570-1

Do not use:

  • More than one patch on your body at a time
  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product.
Section 51727-6

Inactive Ingredients: Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaoloin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Section 53413-1

​Questions or comments: 833.711.8833

Section 53414-9

If pregnant or breastfeeding: Ask a health professional before use.

Warnings
  • For external use only
Other Information:
  • Avoid storing product in direct sunlight.
  • Protect product from excessive moisture.

Active Ingredients:

Lidocaine 4%

Principal Display Panel

NDC 82944-103-01

LIDOCORE

Lidocaine 4% Topical Anesthetic

TOPICAL PAIN PATCH

For Temporary Pain Relief

Flexible Patch Innovation

Soothing and Effective

Long Lasting Relief

1 PATCH

5.5 x 3.94 (14cm x 10cm)

APPLY FOR 8 HOURS

ION PHARMA


Structured Label Content

Indications and Usage (34067-9)

Uses: For temporary relief of pain.

Dosage and Administration (34068-7)

Directions: Adults, or children over the age of 12: 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-hour application. Children under 12 years of age: Consult a doctor.

Section 50565-1 (50565-1)

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and consult a doctor if:

  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering.
  • Conditions worsen
  • Symptoms persist more than 7 days
  • Symptoms clear up and occur again within a few days.
Section 50567-7 (50567-7)

When using this product:

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly.
Section 50570-1 (50570-1)

Do not use:

  • More than one patch on your body at a time
  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product.
Section 51727-6 (51727-6)

Inactive Ingredients: Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaoloin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Section 53413-1 (53413-1)

​Questions or comments: 833.711.8833

Section 53414-9 (53414-9)

If pregnant or breastfeeding: Ask a health professional before use.

Purpose

Topical anesthetic

Warnings
  • For external use only
Other Information:
  • Avoid storing product in direct sunlight.
  • Protect product from excessive moisture.

Active Ingredients: (Active ingredients:)

Lidocaine 4%

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 82944-103-01

LIDOCORE

Lidocaine 4% Topical Anesthetic

TOPICAL PAIN PATCH

For Temporary Pain Relief

Flexible Patch Innovation

Soothing and Effective

Long Lasting Relief

1 PATCH

5.5 x 3.94 (14cm x 10cm)

APPLY FOR 8 HOURS

ION PHARMA


Advanced Ingredient Data


Raw Label Data

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