Lidocaine 4% Pain Relief Gel Patch

Lidocaine 4% Pain Relief Gel Patch
SPL v1
SPL
SPL Set ID 8e5a4ef4-b928-44b3-842c-92f1531af75b
Route
TOPICAL
Published
Effective Date 2025-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Aluminum Glycinate Aluminum Hydroxide Aluminum Borate Carbomer Dmdm Hydantoin Aluminum Sulfate Glycerin Kaolin Polyacrylic Acid (250000 Mw) Polyvinyl Alcohol (100000 Mw) Povidone K27 Propylene Glycol Water Carboxymethylcellulose Sodium Magnesium Disodium Edta Sodium Polyacrylate (2500000 Mw) Sorbitol Sorbitol Monooleate Tartaric Acid Titanium Dioxide .alpha.-tocopherol Acetate Butylated Hydroxytoluene Polysorbate 20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-03

Description

Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

Use

Temporarily relieves minor pain

Warnings

For external use only

Directions:

Adult and children over 12years:

  • Clean and dry affected area
  • remove backing from patch by firmly grasping both ends and
  • gently pulling until back separates in middle
  • Carefully remove smaller portion of backing from the patch and apply exposed portion of
  • patch to affected area 
  • use 1 patch for up to 12 hours
children 12 years or younger: ask a doctor
Do Not Use:
  • more than 1 patch on your body at a time
  • on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor
  • at the same time as other topical analgesics

Active Ingredient

Lidocaine 4%

Package Label Box

Other Information:

Store at room temperature 20·25'C (68-77'F)

Questions? call toll-free 1-844-912-4012

Inactive Ingredients:

Alpha Tocopherol, Aluminum Sulphate, Borax, Carbomer, Colloidal Silicon Dioxide, DMDM Hydantoin, Glycerin, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone , Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitol Monooleate , Tartaric Acid & Titanium Dioxide, Butylated Hydroxytoluene, Polysorbate

When Using This Product:

• use only as directed.

• read and follow all directions and warnings on this label

• rare cases of serious burns have been reported with products of this type.

• do not apply to wounds or damaged, broken

• eyes and mucous membranes

• do not bandage tightly or apply local heat (such as

• the same time as other topical analgesics

• 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.

• a transient burning sensation may occur upon application but generally disappears in several days

• if a severe burning sensation occurs, discontinue use immediately.

• discontinue use at least 1 hour before a bath or shower.

• do not use immediately after a bath or shower.

Stop Use and Ask Doctor If:

• condition worsen

• redness is present

• irritation develops

• symptoms persist for more than 7 days or clear up and occur again within a few days

• you experience signs of skin injury, such as pain, swelling, or blistering where this product is applied

If Pregnant Or Breast Feeding, 

ask a health professional before use.

Keep Out of Reach of Children and Pets

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

Temporarily relieves minor pain

Purpose

Topical Anesthetic

Warnings

For external use only

Directions:

Adult and children over 12years:

  • Clean and dry affected area
  • remove backing from patch by firmly grasping both ends and
  • gently pulling until back separates in middle
  • Carefully remove smaller portion of backing from the patch and apply exposed portion of
  • patch to affected area 
  • use 1 patch for up to 12 hours
children 12 years or younger: ask a doctor
Do Not Use: (Do not use:)
  • more than 1 patch on your body at a time
  • on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor
  • at the same time as other topical analgesics

Active Ingredient (Active ingredient)

Lidocaine 4%

Package Label Box

Other Information:

Store at room temperature 20·25'C (68-77'F)

Questions? call toll-free 1-844-912-4012

Inactive Ingredients: (Inactive ingredients:)

Alpha Tocopherol, Aluminum Sulphate, Borax, Carbomer, Colloidal Silicon Dioxide, DMDM Hydantoin, Glycerin, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone , Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitol Monooleate , Tartaric Acid & Titanium Dioxide, Butylated Hydroxytoluene, Polysorbate

When Using This Product: (When using this product:)

• use only as directed.

• read and follow all directions and warnings on this label

• rare cases of serious burns have been reported with products of this type.

• do not apply to wounds or damaged, broken

• eyes and mucous membranes

• do not bandage tightly or apply local heat (such as

• the same time as other topical analgesics

• 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.

• a transient burning sensation may occur upon application but generally disappears in several days

• if a severe burning sensation occurs, discontinue use immediately.

• discontinue use at least 1 hour before a bath or shower.

• do not use immediately after a bath or shower.

Stop Use and Ask Doctor If: (Stop use and ask doctor if:)

• condition worsen

• redness is present

• irritation develops

• symptoms persist for more than 7 days or clear up and occur again within a few days

• you experience signs of skin injury, such as pain, swelling, or blistering where this product is applied

If Pregnant Or Breast Feeding,  (if pregnant or breast feeding, )

ask a health professional before use.

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 right away.


Advanced Ingredient Data


Raw Label Data

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