SPL v1
SPL
SPL Set ID 460d6b66-1787-df4f-e063-6294a90a4c2e
Route
TOPICAL
Published
Effective Date 2025-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-16

Description

Lidocaine 4% ---- PURPOSE Topical analgesic


Medication Information

Warnings and Precautions

For external use only

Do not use:

1.More than 1 patch at atime. 2.0n wounds or damaged skin. 3.With a heating pad. 4.lf you are allergic to any ingredients

of this product.

Indications and Usage

Adults and children 12 years of age and over:

1. Clean and dry affected area. 2.Remove film from patch and apply to the skin (see illustration). 3.Apply 1 patch at a time

to affected area, not more than 3 to 4 times daily. 4.Remove patch from the skin after at most 8-hour application.

Dosage and Administration

Apply 1 patch at a time

to affected area, not more than 3 to 4 times daily

Description

Lidocaine 4% ---- PURPOSE Topical analgesic

Section 50565-1

Keep out of reach of children

Section 51727-6

INACTIVE INGREDIENTS

ALUMINUM SILICATE, DIHYDROXYALUMINUM AMINOACETATE, DISODIUM EDETATE, GELATIN, GLYCERIN, METHYLPARABENOLEIC ACID, POLYACRYLIC ACID, POLYVINYL ALCOHOL, PROPYLENE GLYCOL, PROPYLPARABEN, SODIUM POLYACRYLATETARTARIC ACID, TITANIUM DIOXIDE, WATER

Section 51945-4

Section 55105-1

Uses for temporary relief of pain:

1.Fold sides back, pull apart to expose adhesive. 2.Place on affected area. 3.Peel off one side of the film. 4.Peel off the

remaining film.5.Press and smooth patch to secure.

Section 55106-9

Lidocaine 4% ----

PURPOSE

Topical analgesic


Structured Label Content

Indications and Usage (34067-9)

Adults and children 12 years of age and over:

1. Clean and dry affected area. 2.Remove film from patch and apply to the skin (see illustration). 3.Apply 1 patch at a time

to affected area, not more than 3 to 4 times daily. 4.Remove patch from the skin after at most 8-hour application.

Dosage and Administration (34068-7)

Apply 1 patch at a time

to affected area, not more than 3 to 4 times daily

Warnings and Precautions (34071-1)

For external use only

Do not use:

1.More than 1 patch at atime. 2.0n wounds or damaged skin. 3.With a heating pad. 4.lf you are allergic to any ingredients

of this product.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS

ALUMINUM SILICATE, DIHYDROXYALUMINUM AMINOACETATE, DISODIUM EDETATE, GELATIN, GLYCERIN, METHYLPARABENOLEIC ACID, POLYACRYLIC ACID, POLYVINYL ALCOHOL, PROPYLENE GLYCOL, PROPYLPARABEN, SODIUM POLYACRYLATETARTARIC ACID, TITANIUM DIOXIDE, WATER

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses for temporary relief of pain:

1.Fold sides back, pull apart to expose adhesive. 2.Place on affected area. 3.Peel off one side of the film. 4.Peel off the

remaining film.5.Press and smooth patch to secure.

Section 55106-9 (55106-9)

Lidocaine 4% ----

PURPOSE

Topical analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)