walgreens lidocaine 4% patch back, 6 patches

walgreens lidocaine 4% patch back, 6 patches
SPL v2
SPL
SPL Set ID e6bfd342-c0db-46b9-b5e6-5acbd860adf1
Route
topical
Published
Effective Date 2025-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (40 mg)
Inactive Ingredients
.alpha.-tocopherol acetate dihydroxyaluminum aminoacetate glycerin laurocapram peg-40 hydrogenated castor oil phenoxyethanol propylene glycol tartaric acid titanium dioxide urea vanillyl butyl ether water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-10-20

Purpose

Topical Analgesic

Description

Lidocaine 4%


Medication Information

Warnings

For external use only

Purpose

Topical Analgesic

Directions

Adults and children 12 years if age and over:

  • Clean and dry affected area
  • Carefully remove backing from patch
  • Apply sticky side of patch to affected area
  • Use one patch for up to 8 hours
  • Discard patch after single use
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily

Children under 12 years of age: consult a physician.

Other Information
  • Store in a clean, dry place outside of direct sunlight
  • Protect from excessive moisture
Inactive Ingredients

A-tocopherol Acetate, CMC-2Na, Dihydroxyaluminum Aminoacetate, Fumed Silica, Glycerol, Laurocapram, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Urea, Vanillyl Butyl Ether, Water, 3-2-(Ethylhexyl)oxyl-1, 2-Propanediol.

Description

Lidocaine 4%

Use

For temporary relief of pain

Do Not Use
  • More than one patch on your body at a time
  • On cut, irritated or swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor
  • If you are allergic to any active or inactive ingredients 
  • If pouch is damaged or opened
Drug Facts

Active Ingredient

Lidocaine 4%

Package Labelling:

When Using This Product
  • Use only as directed
  • Read and follow all directions and warnings
  • Do not allow contact with the eyes
  • Do not use at the same time as other topical anesthetics
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • 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
  • condition worsen 
  • 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.

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


Structured Label Content

Warnings

For external use only

Purpose

Topical Analgesic

Directions

Adults and children 12 years if age and over:

  • Clean and dry affected area
  • Carefully remove backing from patch
  • Apply sticky side of patch to affected area
  • Use one patch for up to 8 hours
  • Discard patch after single use
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily

Children under 12 years of age: consult a physician.

Other Information (Other information)
  • Store in a clean, dry place outside of direct sunlight
  • Protect from excessive moisture
Inactive Ingredients (Inactive ingredients)

A-tocopherol Acetate, CMC-2Na, Dihydroxyaluminum Aminoacetate, Fumed Silica, Glycerol, Laurocapram, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Urea, Vanillyl Butyl Ether, Water, 3-2-(Ethylhexyl)oxyl-1, 2-Propanediol.

Use

For temporary relief of pain

Do Not Use (Do not use)
  • More than one patch on your body at a time
  • On cut, irritated or swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor
  • If you are allergic to any active or inactive ingredients 
  • If pouch is damaged or opened
Drug Facts

Active Ingredient (Active ingredient)

Lidocaine 4%

Package Labelling:

When Using This Product (When using this product)
  • Use only as directed
  • Read and follow all directions and warnings
  • Do not allow contact with the eyes
  • Do not use at the same time as other topical anesthetics
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • 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)
  • condition worsen 
  • 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. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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