Lenzapro Flex Patch

Lenzapro Flex Patch
SPL v7
SPL
SPL Set ID ba498f1d-460b-f4e6-e053-2995a90a5755
Route
TOPICAL
Published
Effective Date 2021-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg) Lidocaine
Inactive Ingredients
Acrylic Acid

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-01

Description

Active ingredients: Lidocaine HCL 4% Menthol 4%


Medication Information

Warnings and Precautions

Warnings:

For external use

Indications and Usage

Uses:

For the temporary relief of pain

Dosage and Administration

Directions:

Adults and children over 12 years:

  • Clean and dry the affected area.
  • Open pouch and remove one patch.
  • Remove the protective film from the patch and apply patch to the affected area.
  • Reseal pouch containing unused patches after each use.
  • Use 1 patch for up to 12 hours.

Children 12 years or younger:

  • Ask a doctor
Description

Active ingredients: Lidocaine HCL 4% Menthol 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 ask a doctor if:

  • Condition worsens
  • Redness is present
  • Irritation developes
  • Symptoms persist for more than 7 days or clear up and occur again within a few days.
  • You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.
Section 50567-7

When using this product:

  • Use only as directed. Read and follow all directions and warnings on this label.
  • Rare cases of serious burns have been reported with products of this type.
  • Do not apply to wounds or damaged, broken or irritated skin.
  • Do not allow contact with the eyes and mucous membranes.
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
  • Do not use at the same time as other topical analgesics.
  • Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Section 50570-1

Do not use:

  • More than 1 patch on your body at a time or on cut, iritated or swollen skin.
  • On puncture wounds
  • For more than 1 week without consulting a doctor
Section 51727-6

Other Ingredients:

Acrylic Adhesive

Section 51945-4

Questions or comments? 866-747-7365

Manufactured For:

SOLA Pharmaceuticals LLC

Baton Rouge, LA 70810

NDC: 70512-013-15

QTY: 15 Articulated patches (5 per Resealable Pouch) x 3

Section 53414-9

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

Section 55105-1

Purpose:

Topical Anesthetic

Section 55106-9

Active ingredients:

Lidocaine HCL 4%

Menthol 4%

Section 60561-8

Other Information:

  • Avoid storing product in direct sunlight
  • Protect product from excessive mositure

Structured Label Content

Indications and Usage (34067-9)

Uses:

For the temporary relief of pain

Dosage and Administration (34068-7)

Directions:

Adults and children over 12 years:

  • Clean and dry the affected area.
  • Open pouch and remove one patch.
  • Remove the protective film from the patch and apply patch to the affected area.
  • Reseal pouch containing unused patches after each use.
  • Use 1 patch for up to 12 hours.

Children 12 years or younger:

  • Ask a doctor
Warnings and Precautions (34071-1)

Warnings:

For external use

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 ask a doctor if:

  • Condition worsens
  • Redness is present
  • Irritation developes
  • Symptoms persist for more than 7 days or clear up and occur again within a few days.
  • You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.
Section 50567-7 (50567-7)

When using this product:

  • Use only as directed. Read and follow all directions and warnings on this label.
  • Rare cases of serious burns have been reported with products of this type.
  • Do not apply to wounds or damaged, broken or irritated skin.
  • Do not allow contact with the eyes and mucous membranes.
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
  • Do not use at the same time as other topical analgesics.
  • Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Section 50570-1 (50570-1)

Do not use:

  • More than 1 patch on your body at a time or on cut, iritated or swollen skin.
  • On puncture wounds
  • For more than 1 week without consulting a doctor
Section 51727-6 (51727-6)

Other Ingredients:

Acrylic Adhesive

Section 51945-4 (51945-4)

Questions or comments? 866-747-7365

Manufactured For:

SOLA Pharmaceuticals LLC

Baton Rouge, LA 70810

NDC: 70512-013-15

QTY: 15 Articulated patches (5 per Resealable Pouch) x 3

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose:

Topical Anesthetic

Section 55106-9 (55106-9)

Active ingredients:

Lidocaine HCL 4%

Menthol 4%

Section 60561-8 (60561-8)

Other Information:

  • Avoid storing product in direct sunlight
  • Protect product from excessive mositure

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)