Lidocore

Lidocore
SPL v3
SPL
SPL Set ID 12dec398-1082-45ad-a517-8f12873b1909
Route
TOPICAL
Published
Effective Date 2023-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Acrylic Acid Linseed Oil Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-01

Description

Drug Facts Active Ingredients Lidocaine 4% Purpose Topical Anesthetic Uses: For the temporary relief of pain Warnings: For external use only DO NOT USE Do not use - more than 1 patch at a time - on wounds or damaged skin - with a heating pad - or if you are allergic to any ingredients of this product WHEN USING When using this product - use only as directed - avoid contact with eyes, mucous membranes or rashes - do not bandage tightly STOP USE Stop use and ask a doctor if - localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering - conditions worsen - symptoms persist for more than 7 ... PREGNANCY OR BREAST FEEDING If pregnant or breast-feeding, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Drug Facts Active Ingredients Lidocaine 4% Purpose Topical Anesthetic Uses: For the temporary relief of pain Warnings: For external use only DO NOT USE Do not use - more than 1 patch at a time - on wounds or damaged skin - with a heating pad - or if you are allergic to any ingredients of this product WHEN USING When using this product - use only as directed - avoid contact with eyes, mucous membranes or rashes - do not bandage tightly STOP USE Stop use and ask a doctor if - localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering - conditions worsen - symptoms persist for more than 7 ... PREGNANCY OR BREAST FEEDING If pregnant or breast-feeding, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses:

For the temporary relief of pain

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • conditions worsen
  • symptoms persist for 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 eyes, mucous membranes or rashes
  • do not bandage tightly

Section 50570-1

Do not use

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • or if you are allergic to any ingredients of this product

Section 51727-6

Other ingredients: Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

Warnings:

For external use only

Directions

Adults and children 12 years of age and over:

  • Clean and dry the affected area
  • Open pouch and remove one patch
  • Apply 1 patch at a time to affected area; not more than 3 to 4 times daily
  • Reseal pouch containing unused patches after each use
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age:consult a doctor

Drug Facts

Drug Facts

Active Ingredients

Lidocaine 4%

Purpose

Topical Anesthetic

Uses:

For the temporary relief of pain

Warnings:

For external use only

DO NOT USE

Do not use - more than 1 patch at a time - on wounds or damaged skin - with a heating pad - or if you are allergic to any ingredients of this product

WHEN USING

When using this product - use only as directed - avoid contact with eyes, mucous membranes or rashes - do not bandage tightly

STOP USE

Stop use and ask a doctor if - localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering - conditions worsen - symptoms persist for more than 7 ...

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

Question Section

​Questions or comments? 833.711.8833

Active Ingredients

Lidocaine 4%

Other Information:
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Principal Display Panel

NDC 82944-100-10

LIDOCORE

Lidocaine 4% Topical Anesthetic

TOPICAL PAIN PATCH

For Temporary Pain Relief

Flexible Patch Innovation

Soothing and Effective

Long Lasting Relief

MADE IN USA

Qty: 10 Flexible Patches

(5 per Resealable Pouch) x2

3 x 5 (7.62cm x 12.7cm)

ION PHARMA

Pregnancy Or Breast Feeding Section

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


Structured Label Content

Uses:

For the temporary relief of pain

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • conditions worsen
  • symptoms persist for 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 eyes, mucous membranes or rashes
  • do not bandage tightly

Section 50570-1 (50570-1)

Do not use

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • or if you are allergic to any ingredients of this product

Section 51727-6 (51727-6)

Other ingredients: Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

Purpose

Topical Anesthetic

Warnings:

For external use only

Directions

Adults and children 12 years of age and over:

  • Clean and dry the affected area
  • Open pouch and remove one patch
  • Apply 1 patch at a time to affected area; not more than 3 to 4 times daily
  • Reseal pouch containing unused patches after each use
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age:consult a doctor

Drug Facts

Drug Facts

Active Ingredients

Lidocaine 4%

Purpose

Topical Anesthetic

Uses:

For the temporary relief of pain

Warnings:

For external use only

DO NOT USE

Do not use - more than 1 patch at a time - on wounds or damaged skin - with a heating pad - or if you are allergic to any ingredients of this product

WHEN USING

When using this product - use only as directed - avoid contact with eyes, mucous membranes or rashes - do not bandage tightly

STOP USE

Stop use and ask a doctor if - localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering - conditions worsen - symptoms persist for more than 7 ...

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

Question Section

​Questions or comments? 833.711.8833

Active Ingredients

Lidocaine 4%

Other Information: (Other information:)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 82944-100-10

LIDOCORE

Lidocaine 4% Topical Anesthetic

TOPICAL PAIN PATCH

For Temporary Pain Relief

Flexible Patch Innovation

Soothing and Effective

Long Lasting Relief

MADE IN USA

Qty: 10 Flexible Patches

(5 per Resealable Pouch) x2

3 x 5 (7.62cm x 12.7cm)

ION PHARMA

Pregnancy Or Breast Feeding Section (Pregnancy or breast feeding section)

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


Advanced Ingredient Data


Raw Label Data

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