73557-185

73557-185
SPL v1
SPL
SPL Set ID 412fd7c8-1e05-1779-e063-6294a90a3de4
Route
TOPICAL
Published
Effective Date 2025-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.04 g)
Inactive Ingredients
Polysorbate 80 Glycerin Povidone K90 Methylparaben Propylparaben Edetate Disodium Kaolin Tartaric Acid Water Propylene Glycol Polyacrylic Acid (250000 Mw) Sodium Polyacrylate (2500000 Mw) Titanium Dioxide Dihydroxyaluminum Aminoacetate Anhydrous

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-15
Description

Lidocaine 4% ...... Purpose: Topical Anesthetic

Purpose

Topical Anesthetic

Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4% ...... Purpose: Topical Anesthetic

Uses

For temporary relief of pain

Warnings

For external use only

Directions

Adult and Children 12 years of age and over:

  • Clean and dry affected area
  • Remove film from patch and apply to the skin (see illustration)
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age: Consult a doctor

Do Not Use
  • More than 1 patch at a time
  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product
Stop Use If:
  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persists for more than 7 days
  • Symptoms clear up and occur again within a few days
Ask A Doctor If:
  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persists for more than 7 days
  • Symptoms clear up and occur again within a few days
Active Ingredient

Lidocaine 4% ...... Purpose: Topical Anesthetic

Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Inactive Ingredients

Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Povidone, Methylparaben, Propylparaben, Water

Questions Or Comments?

86-21-31166566；[email protected]

When Using This Product
  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashed
  • Do not bandage tightly
Pregnancy Or Breast Feeding

If pregnant or breastfeeding, 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.

Package Label. Principal Display Panel

Structured Label Content

Uses

For temporary relief of pain

Purpose

Topical Anesthetic

Warnings

For external use only

Directions

Adult and Children 12 years of age and over:

  • Clean and dry affected area
  • Remove film from patch and apply to the skin (see illustration)
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age: Consult a doctor

Do Not Use (Do not use)
  • More than 1 patch at a time
  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product
Stop Use If: (Stop use if:)
  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persists for more than 7 days
  • Symptoms clear up and occur again within a few days
Ask A Doctor If: (Ask a doctor if:)
  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persists for more than 7 days
  • Symptoms clear up and occur again within a few days
Active Ingredient (Active ingredient)

Lidocaine 4% ...... Purpose: Topical Anesthetic

Other Information (Other information)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Inactive Ingredients (Inactive ingredients)

Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Povidone, Methylparaben, Propylparaben, Water

Questions Or Comments? (Questions or Comments?)

86-21-31166566；[email protected]

When Using This Product (When using this product)
  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashed
  • Do not bandage tightly
Pregnancy Or Breast Feeding (Pregnancy or breast feeding)

If pregnant or breastfeeding, ask a health professional before use

Keep Out of Reach of Children (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.

Package Label. Principal Display Panel (Package label. Principal display panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:42.875677 · Updated: 2026-03-14T23:13:03.799451