Maximum Strength 4% Lidocaine Patch

Maximum Strength 4% Lidocaine Patch
SPL v1
SPL
SPL Set ID 43f3d189-f6b7-02ed-e063-6394a90afd73
Route
TOPICAL
Published
Effective Date 2025-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Tartaric Acid Titanium Dioxide Carboxymethylcellulose Sodium Dihydroxyaluminum Aminoacetate Glycerin Edetate Disodium Anhydrous Methylparaben Sodium Polyacrylate (2500000 Mw) Propylene Glycol Polyvinyl Alcohol, Unspecified Propylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-06

Description

Lidocaine 4%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Lidocaine 4%

Uses

For temporary relief of pain

Warnings

For external use only

Directions

Adults and children over 2 years:

  • clean and dry affected area free of lotions, ointments and creams.
  • carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area.
  • Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discar patch after single use.

children 2 years or younger:ask a physician.

Do Not Use
  • more than 1 patch on your body at a time or on cut, irritated or swollen skin
  • for more than one week without consulting a doctor
  • over raw surfaces or blistered areas
  • if pouch is damaged or opened
Active Ingredient

Lidocaine 4%

Bulk Package Label

Inactive Ingredients

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

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
Stop Use and Ask A Doctor If
  • condition worsens
  • skin irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
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

For temporary relief of pain

Purpose

External Analgesic

Warnings

For external use only

Directions

Adults and children over 2 years:

  • clean and dry affected area free of lotions, ointments and creams.
  • carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area.
  • Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discar patch after single use.

children 2 years or younger:ask a physician.

Do Not Use
  • more than 1 patch on your body at a time or on cut, irritated or swollen skin
  • for more than one week without consulting a doctor
  • over raw surfaces or blistered areas
  • if pouch is damaged or opened
Active Ingredient

Lidocaine 4%

Bulk Package Label

Inactive Ingredients

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

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
Stop Use and Ask A Doctor If (Stop Use and Ask a Doctor if)
  • condition worsens
  • skin irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
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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