Lidopro Patch

Lidopro Patch
SPL v1
SPL
SPL Set ID 128d0ba9-bc9d-af16-e063-6394a90af5ef
Route
TOPICAL
Published
Effective Date 2024-02-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 mg) Menthol (0.5 mg) Salicylic Acid (0.1 mg)
Inactive Ingredients
Polysorbate 80 Water Glycerin Polyacrylic Acid (250000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-29

Description

Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

Uses

Temporarily relieves minor pain

Warnings

For external use only

Directions

ad ults and children over 12 years:

  • clean and dry the affected area
  • remove patch from plastic liner and place on the affected area
  • use 1 patch for up to 12 hours
  • place used patch on the liner when not in use
  • re-use the patch up to 2 times.

children 12 years or younger: ask a doctor

Distributed by

Advanced Rx Pharmacy of Tennessee, LLC

Do Not Use

• more than one patch on your bidy at a time or on cuts, irritated, or swollen skin

• on puncture wounds

• for more than one week without consulting a doctor.

If Pregnant Or

ask health professional before use.

Active Ingredient

Lidocaine 4%

Other Ingredients:

Vegan Glycerol, Polyacrylate, Aqua. Polysorbate 80

Principal Display Panel

When Using This Product
  • Use only as directed. Read and follow directions and warning on this packaging.
  • Do not apply to wounds or damaged, broken, or irritated skin
  • Avoid contact with the eyes or mucous membranes
  • Do not bandage tightly or apply local heat (such as heating pads) to 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.

Stop Use and Ask A Doctor If
  • conditions worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of injury, such as pain, swelling, or blistering where the product was applied
Keep Out of Reach of Children and Pets.

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


Structured Label Content

Uses

Temporarily relieves minor pain

Purpose

Topical Anesthetic

Warnings

For external use only

Directions (DIRECTIONS)

ad ults and children over 12 years:

  • clean and dry the affected area
  • remove patch from plastic liner and place on the affected area
  • use 1 patch for up to 12 hours
  • place used patch on the liner when not in use
  • re-use the patch up to 2 times.

children 12 years or younger: ask a doctor

Distributed by

Advanced Rx Pharmacy of Tennessee, LLC

Do Not Use (Do not use)

• more than one patch on your bidy at a time or on cuts, irritated, or swollen skin

• on puncture wounds

• for more than one week without consulting a doctor.

If Pregnant Or (If pregnant or)

ask health professional before use.

Active Ingredient

Lidocaine 4%

Other Ingredients: (OTHER INGREDIENTS:)

Vegan Glycerol, Polyacrylate, Aqua. Polysorbate 80

Principal Display Panel

When Using This Product (When using this product)
  • Use only as directed. Read and follow directions and warning on this packaging.
  • Do not apply to wounds or damaged, broken, or irritated skin
  • Avoid contact with the eyes or mucous membranes
  • Do not bandage tightly or apply local heat (such as heating pads) to 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.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • conditions worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of injury, such as pain, swelling, or blistering where the product was applied
Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

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


Advanced Ingredient Data


Raw Label Data

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