SPL v2
SPL
SPL Set ID f765a716-5e52-3daf-e053-6394a90acef0
Route
TOPICAL
Published
Effective Date 2023-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (84 mg)
Inactive Ingredients
Alpha-tocopherol Acetate Sodium Polyacrylate (8000 Mw) Sorbitan Monooleate Polyacrylic Acid (250000 Mw) Carbomer 940 Aluminum Hydroxide Glycerin Kaolin Polyvinyl Alcohol (100000 Mw) Tartaric Acid Titanium Dioxide Water Sorbitol Dmdm Hydantoin

Identifiers & Packaging

Pill Appearance
Shape: rectangle Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-03-27

Description

Lidocaine 4%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

temporarily relieves minor pain

Dosage and Administration

Topical Patch for External Use Only

Description

Lidocaine 4%

Section 44425-7

Store at room temperature 20-25 0C (68-77 0F)

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.
  • Rare case of serious burns have been reported with products of this type.
  • Do not apply to wounds or damaged, broken or irritated skin.
  • Do not allow contact with the eyes and mucous membranes.
  • 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 analgesic.
  • Dispose of used patch in manner that always 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 uopn 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.
Section 50570-1
  • More than one patch on your body at a time
  • On cut, irritated swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor
  • At the same time as other topical analgesics
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%

Section 59845-8

Adult and children over 12 years

  • 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
Stop Use and Ask A Doctor If
  • 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.

Structured Label Content

Indications and Usage (34067-9)

temporarily relieves minor pain

Dosage and Administration (34068-7)

Topical Patch for External Use Only

Warnings and Precautions (34071-1)

For external use only

Section 44425-7 (44425-7)

Store at room temperature 20-25 0C (68-77 0F)

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.
  • Rare case of serious burns have been reported with products of this type.
  • Do not apply to wounds or damaged, broken or irritated skin.
  • Do not allow contact with the eyes and mucous membranes.
  • 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 analgesic.
  • Dispose of used patch in manner that always 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 uopn 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.
Section 50570-1 (50570-1)
  • More than one patch on your body at a time
  • On cut, irritated swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor
  • At the same time as other topical analgesics
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%

Section 59845-8 (59845-8)

Adult and children over 12 years

  • 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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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.

Advanced Ingredient Data


Raw Label Data

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