Leader Lidocaine Pain Relief Patch 5ct

Leader Lidocaine Pain Relief Patch 5ct
SPL v1
SPL
SPL Set ID 025d508b-ec4f-466c-b3e8-ba9b18d07b46
Route
TOPICAL
Published
Effective Date 2025-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Glycerin Methylparaben Propylene Glycol Propylparaben Sodium Polyacrylate (2500000 Mw) Tartaric Acid Titanium Dioxide Water Dihydroxyaluminum Aminoacetate Polyvinyl Alcohol Edetate Disodium Carboxymethylcellulose Sodium Polyacrylic Acid (8000 Mw)

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-21

Description

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Indications and Usage

Uses: Temporaily relieves minor pains.

Purpose

External analgesic

Dosage and Administration

Directions ■ Adults and children 2 years of age and over: 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 i 2 hour period. Maximum 2 patches per day. Discard patch after single use. ■ Children under 2 years of age: Do not use, ask a doctor


Medication Information

Indications and Usage

Uses: Temporaily relieves minor pains.

Purpose

External analgesic

Dosage and Administration

Directions

■ Adults and children 2 years of age and over: 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 i 2 hour period. Maximum 2 patches per day. Discard patch after single use.

■ Children under 2 years of age: Do not use, ask a doctor

Description

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Section 51945-4
Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Warnings

For external use only.

Questions

CALL TOLL-FREE 1-866-326-1313

Do Not Use
  • Over raw surfaces or blistered areas
Active Ingredients

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Inactive Ingredients

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

When Using This Product

When using this product■avoid contact with the eyes ■ do not use more than one patch on your body

ata time

Other Safety Information

Other information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture. 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 Consult A Doctor

Stop use and ask a doctor if

■ skin irritation develops ■ condition worsens ■symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children and Pets.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Section 51945-4 (51945-4)
Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Purpose

External analgesic

Warnings

For external use only.

Questions

CALL TOLL-FREE 1-866-326-1313

Do Not Use (Do not Use)
  • Over raw surfaces or blistered areas
Active Ingredients

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Inactive Ingredients

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

Indications and Usage

Uses: Temporaily relieves minor pains.

When Using This Product (When using this product)

When using this product■avoid contact with the eyes ■ do not use more than one patch on your body

ata time

Other Safety Information

Other information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture. 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.

Dosage and Administration

Directions

■ Adults and children 2 years of age and over: 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 i 2 hour period. Maximum 2 patches per day. Discard patch after single use.

■ Children under 2 years of age: Do not use, ask a doctor

Stop Use and Consult A Doctor (Stop use and consult a doctor)

Stop use and ask a doctor if

■ skin irritation develops ■ condition worsens ■symptoms persist for more than 7 days or clear up and occur again within a few days

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 (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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