SPL v3
SPL
SPL Set ID 10249d0f-5ee1-6892-e063-6394a90a967e
Route
TOPICAL
Published
Effective Date 2024-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (224 mg) Menthol (56 mg)
Inactive Ingredients
Aluminium Sulfate Octadecahydrate Water Sorbitan Monooleate Polyacrylic Acid (250000 Mw) Kaolin Alpha-tocopherol Acetate Dmdm Hydantoin Sodium Polyacrylate (8000 Mw) Polyvinyl Alcohol (100000 Mw) Tartaric Acid Titanium Dioxide Glycerin Aluminum Hydroxide Propylene Glycol Edetate Disodium Povidone Carboxymethylcellulose Sodium Borax Silicon Dioxide Butylated Hydroxytoluene Dihydroxyaluminum Aminoacetate

Identifiers & Packaging

Pill Appearance
Shape: rectangle Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-30

Description

Lidocaine 4% Menthol 1%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

Dosage and Administration

Topical Patch for external use only

Description

Lidocaine 4% Menthol 1%

Section 50565-1

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

Section 50567-7
  • use only as directed. Read and follow all directions and warnings on this label.
  • do not allow contact with the eyes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Section 50569-3
  • condition worsens
  • 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 the product was applied
Section 50570-1
  • more than 1 patch on your body at a time or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor
Section 51727-6

Alpha Tocopherol Acetate, Aluminium Glycinate, Aluminium Hydroxide, Aluminium Sulphate, Borax, Carbomer, Collodial Silicon Dioxide, DMDM Hydantoin, Glycerine, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartaric Acid & Titanium Dioxide.

Section 51945-4

Section 53413-1

Call +91-905-677-0088

Section 53414-9

ask a health professional before use.

Section 55105-1

Topical Anesthetic

Section 55106-9

Lidocaine 4%

Menthol 1%

Section 59845-8

Adults and children over 12 years:

  • clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 1 patch for up to 12 hours

children 12 years or younger:

  • ask a doctor
Section 60560-0

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

Dosage and Administration (34068-7)

Topical Patch for external use only

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)
  • use only as directed. Read and follow all directions and warnings on this label.
  • do not allow contact with the eyes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Section 50569-3 (50569-3)
  • condition worsens
  • 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 the product was applied
Section 50570-1 (50570-1)
  • more than 1 patch on your body at a time or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor
Section 51727-6 (51727-6)

Alpha Tocopherol Acetate, Aluminium Glycinate, Aluminium Hydroxide, Aluminium Sulphate, Borax, Carbomer, Collodial Silicon Dioxide, DMDM Hydantoin, Glycerine, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartaric Acid & Titanium Dioxide.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call +91-905-677-0088

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Topical Anesthetic

Section 55106-9 (55106-9)

Lidocaine 4%

Menthol 1%

Section 59845-8 (59845-8)

Adults and children over 12 years:

  • clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 1 patch for up to 12 hours

children 12 years or younger:

  • ask a doctor
Section 60560-0 (60560-0)

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.


Advanced Ingredient Data


Raw Label Data

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