Lidocaine Pain Relief Gel-patch (19)

Lidocaine Pain Relief Gel-patch (19)
SPL v1
SPL
SPL Set ID 31a099c4-91d8-352a-e063-6394a90a035f
Route
TOPICAL
Published
Effective Date 2025-03-24
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 2025-03-24

Description

Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

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 12

157 21

157 22

157 23

157 24

157 25

157 26

157 27

157 33

157 34

157 35

157 37

157 38

157 43

157 44

157 45

157 46

517 13

517 14

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%

... 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
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 12 (157-12)

157 21 (157-21)

157 22 (157-22)

157 23 (157-23)

157 24 (157-24)

157 25 (157-25)

157 26 (157-26)

157 27 (157-27)

157 33 (157-33)

157 34 (157-34)

157 35 (157-35)

157 37 (157-37)

157 38 (157-38)

157 43 (157-43)

157 44 (157-44)

157 45 (157-45)

157 46 (157-46)

517 13 (517-13)

517 14 (517-14)

Purpose

Topical Anesthetic

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%

... 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)
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

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