481 - Lidocaine Pain Relief Patch

481 - Lidocaine Pain Relief Patch
SPL v6
SPL
SPL Set ID 7f715144-f0c8-48fc-a22d-eac85759c66a
Route
TOPICAL
Published
Effective Date 2025-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.04 g)
Inactive Ingredients
Sodium Polyacrylate (2500000 Mw) Polyvinyl Alcohol Dihydroxyaluminum Aminoacetate Glycerin Methylparaben Propylene Glycol Propylparaben Tartaric Acid Water Carboxymethylcellulose Sodium, Unspecified Form Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-31

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

Use(s)

For temporary relief of pain

Warnings

For external use only

Directions

Adults and children 12 years of age and over:

  • clean and dry affected area
  • carefully remove the backing from the patch starting at a corner
  • Apply the sticky side of patch to the affected area.
  • Use one patch for up to 12 hours
  • Discard patch after single use

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.
Questions/comments

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Active Ingredient(s)

Lidocaine 4%

Inactive Ingredients

dihydroxy aluminium aminoacetate, disodium EDTA, glycerin, methyl paraben, polyacrylic acid, polyvinyl alcohol, propyl paraben, propylene glycol, sodium carboxy methyl cellulose, sodium polyacrylate, tartaric acid, titanium dioxide, water

Do Not Use If You Have
  • more than one patch on your body at a time
  • on cut 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
Principal Display Panel
When Using This Product
  • use only as directed
  • read and follow all directions and warnings on this carton
  • Do not allow contact with the eyes
  • Do not use at the same time as other topical analgesics
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • Dispose of a used patch in a manner that always keeps the 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 ingest this patch.
Stop Use and Ask A Doctor If
  • conditions 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 an injury, such as pain, swelling, or blistering where the product was applied.
If Pregnant Or Breastfeeding,

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 800-222-1222 right away.


Structured Label Content

Use(s)

For temporary relief of pain

Purpose

Topical anesthetic

Warnings

For external use only

Directions

Adults and children 12 years of age and over:

  • clean and dry affected area
  • carefully remove the backing from the patch starting at a corner
  • Apply the sticky side of patch to the affected area.
  • Use one patch for up to 12 hours
  • Discard patch after single use

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.
Questions/comments (Questions/Comments)

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Active Ingredient(s) (Active ingredient(s))

Lidocaine 4%

Inactive Ingredients (Inactive ingredients)

dihydroxy aluminium aminoacetate, disodium EDTA, glycerin, methyl paraben, polyacrylic acid, polyvinyl alcohol, propyl paraben, propylene glycol, sodium carboxy methyl cellulose, sodium polyacrylate, tartaric acid, titanium dioxide, water

Do Not Use If You Have (Do not use if you have)
  • more than one patch on your body at a time
  • on cut 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
Principal Display Panel
When Using This Product (When using this product)
  • use only as directed
  • read and follow all directions and warnings on this carton
  • Do not allow contact with the eyes
  • Do not use at the same time as other topical analgesics
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • Dispose of a used patch in a manner that always keeps the 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 ingest this patch.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • conditions 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 an injury, such as pain, swelling, or blistering where the product was applied.
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

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 800-222-1222 right away.


Advanced Ingredient Data


Raw Label Data

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