SPL v1
SPL
SPL Set ID 2d76dd9a-6291-ae75-e063-6394a90a30e6
Route
TOPICAL
Published
Effective Date 2024-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.04 g)
Inactive Ingredients
Edetate Disodium Polysorbate 80 Glycerin Povidone K90 Methylparaben Propylparaben 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 2024-10-14
Description

Lidocaine 4% ...... Purpose: Topical Analgesic

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Lidocaine 4% ...... Purpose: Topical Analgesic

Uses

Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows.

Usage

1. Remove patch from outer package

2. Partially peel back protection film

3. Place on affected area

4. Remove remaining film while pressing patch to skin

157 16

157 18

157 19

157 28

157 29

157 31

157 32

157 36

157 39

157 40

157 41

157 42

517 17

517 20

Warnings

For external use only

Directions

Adults and Children above 12 years old:

■ Clean and dry the affected area.

■ Tear off the proctive film and apply the exposed part of the patch to the affected area.

■ Carefully remove remaining film while pressing the patch firmly on the skin.

■ Remove patch from the skin after at most 8-hour application.

Children under age of 12: Consult a doctor

Do Not Use

■ on wounds or damaged skin

■ with a heating pad or device

■ with other ointments, creams, sprays, or liniments

■ if you are allergic to any ingredients of this product

Stop Use ... If

■ skin reactions such as redness, swelling, blistering or other discomfort occur

■ symptoms persist for more than 7 days

Active Ingredient

Lidocaine 4% ...... Purpose: Topical Analgesic

... Ask A Doctor If

■ skin reactions such as redness, swelling, blistering or other discomfort occur

■ symptoms persist for more than 7 days

Inactive Ingredients

Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone 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

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

If swallowed accidentally, get medical help or contact with Poison Control Center immediately.

Structured Label Content

Uses

Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows.

Usage

1. Remove patch from outer package

2. Partially peel back protection film

3. Place on affected area

4. Remove remaining film while pressing patch to skin

157 16 (157-16)

157 18 (157-18)

157 19 (157-19)

157 28 (157-28)

157 29 (157-29)

157 31 (157-31)

157 32 (157-32)

157 36 (157-36)

157 39 (157-39)

157 40 (157-40)

157 41 (157-41)

157 42 (157-42)

517 17 (517-17)

517 20 (517-20)

Purpose

Topical Analgesic

Warnings

For external use only

Directions

Adults and Children above 12 years old:

■ Clean and dry the affected area.

■ Tear off the proctive film and apply the exposed part of the patch to the affected area.

■ Carefully remove remaining film while pressing the patch firmly on the skin.

■ Remove patch from the skin after at most 8-hour application.

Children under age of 12: Consult a doctor

Do Not Use (Do not use)

■ on wounds or damaged skin

■ with a heating pad or device

■ with other ointments, creams, sprays, or liniments

■ if you are allergic to any ingredients of this product

Stop Use ... If (Stop use ... if)

■ skin reactions such as redness, swelling, blistering or other discomfort occur

■ symptoms persist for more than 7 days

Active Ingredient (Active ingredient)

Lidocaine 4% ...... Purpose: Topical Analgesic

... Ask A Doctor If (... ask a doctor if)

■ skin reactions such as redness, swelling, blistering or other discomfort occur

■ symptoms persist for more than 7 days

Inactive Ingredients (Inactive ingredients)

Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone 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

If Pregnant 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:29.538102 · Updated: 2026-03-14T23:07:24.321893