Lidocaine With Menthol Patch Pain Relief- Lidocaine 4% And Menthol 1% Patch

Lidocaine With Menthol Patch Pain Relief- Lidocaine 4% And Menthol 1% Patch
SPL v1
SPL
SPL Set ID bb989956-3e09-480e-95c2-3c9cef5131a4
Route
TOPICAL
Published
Effective Date 2021-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg) Menthol (10 mg)
Inactive Ingredients
Kaolin Polysorbate 80 Polyacrylic Acid (250000 Mw) Silicon Dioxide Sodium Polyacrylate (2500000 Mw) Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-01-26

Description

Lidocaine 4% Menthol 1%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4% Menthol 1%

Uses

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

Warning

For external use only

Do Not Use
  • more than 1 patch on your body at a time or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor
Directions:

Adults and children over 12 years:

  • clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 1 patch for up to 12 hours

children 12 years or younger: ask a doctor

Active Ingredient

Lidocaine 4%

Menthol 1%

Inactive Ingredients

kaolin, polysorbate 80, polyacrylic acid, silicon dioxide, sodium polyacrylate, titanium dioxide

Package / Inner Pouch

When Using This Product
  • use only as directed. Read and follow all directions and warnings on this label.
  • do not allow contact with the eyes
  • 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 or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Package / Principle Label

Stop Use and Ask A Doctor If
  • condition 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 skin injury, such as pain, swelling, or blistering where the product was applied
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 a Poison Control Center right away.

Structured Label Content

Uses

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

Purpose

Topical Anesthetic

Warning

For external use only

Do Not Use (Do not Use)
  • more than 1 patch on your body at a time or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor
Directions:

Adults and children over 12 years:

  • clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 1 patch for up to 12 hours

children 12 years or younger: ask a doctor

Active Ingredient (Active ingredient)

Lidocaine 4%

Menthol 1%

Inactive Ingredients

kaolin, polysorbate 80, polyacrylic acid, silicon dioxide, sodium polyacrylate, titanium dioxide

Package / Inner Pouch

When Using This Product
  • use only as directed. Read and follow all directions and warnings on this label.
  • do not allow contact with the eyes
  • 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 or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Package / Principle Label

Stop Use and Ask A Doctor If (Stop Use and Ask a Doctor if)
  • condition 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 skin injury, such as pain, swelling, or blistering where the product was applied
If Pregnant Or Breast Feeding (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 a Poison Control Center right away.

Advanced Ingredient Data


Raw Label Data

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