87253-187

87253-187
SPL v1
SPL
SPL Set ID 45ccfcae-a307-1c5f-e063-6294a90acf89
Route
TOPICAL
Published
Effective Date 2025-09-15
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 2025-12-10
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 the affected area
  • Remove film from patch and apply to the skin
  • 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 or device
  • 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

Inactive Ingredients

Dihydroxyaluminum Aminoacetate, Edetate Disodium,Glycerin, Kaolin, Methylparaben, Polysorbate 80,Propylene Glycol, Polyacrylic Acid, Povidone K90,Propylparaben, Sodium Polyacrylate, Tartaric Acid,Titanium Dioxide, Water.

Questions Or Comments?



[email protected]

When Using This Product
  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly
Pregnancy 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 accidentally, get medical help or contact with Poison Control Center immediately.

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 the affected area
  • Remove film from patch and apply to the skin
  • 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 or device
  • 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

Inactive Ingredients (Inactive ingredients)

Dihydroxyaluminum Aminoacetate, Edetate Disodium,Glycerin, Kaolin, Methylparaben, Polysorbate 80,Propylene Glycol, Polyacrylic Acid, Povidone K90,Propylparaben, Sodium Polyacrylate, Tartaric Acid,Titanium Dioxide, Water.

Questions Or Comments? (Questions or Comments?)



[email protected]

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

Keep out of reach of children. If swallowed accidentally, get medical help or contact with Poison Control Center immediately.

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: 2026-02-15T12:07:39.684025 · Updated: 2026-03-14T23:11:20.857564