Maximum Strength Lidocaine Patch

Maximum Strength Lidocaine Patch
SPL v2
SPL
SPL Set ID 6599240c-8610-4461-9a6c-a38b14dcdd69
Route
TOPICAL
Published
Effective Date 2017-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Algeldrate Bentonite Carbomer 940 Carboxymethylcellulose Sodium Dihydroxyaluminum Aminoacetate Edetate Disodium Anhydrous Gelatin Glycerin Oleic Acid Polysorbate 80 Polyvinyl Alcohol, Unspecified Potassium Sorbate Povidone Propylene Glycol Sodium Metabisulfite Silicon Dioxide Sodium Borate Trolamine Tartaric Acid Urea Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-03-06

Description

Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

Uses

Temporarily relieves minor pain

Warnings

For external use only

Directions

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

Do Not Use
  • 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
Active Ingredient

Lidocaine 4%

Inactive Ingredients

aluminium hydroxide gel, bentonite, borax, carbomer, carboxymethylcellulose sodium,

colloidal silicon dioxide, dihydroxyaluminumaminoacetate, disodiumedetate, gelatin, glycerin, oleic acid, polysorbate 80, polyvinyl Alcohol, potassium Sorbate, povidone, propylene glycol, sodiummetabisulphite, tartaric acid, trolamine, urea, water

When Using This Product
  • 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.
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
If Pregnant Or Breast Feeding

ask a health professional before use.

Package/label Principal Display Panel

MAX STRENGTH LIDOCAINE  PATCH

-NUMBS AWAY PAIN

Keep Out of Reach of Children and Pets

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


Structured Label Content

Uses

Temporarily relieves minor pain

Purpose

Topical Anesthetic

Warnings

For external use only

Directions

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

Do Not Use
  • 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
Active Ingredient (Active ingredient)

Lidocaine 4%

Inactive Ingredients

aluminium hydroxide gel, bentonite, borax, carbomer, carboxymethylcellulose sodium,

colloidal silicon dioxide, dihydroxyaluminumaminoacetate, disodiumedetate, gelatin, glycerin, oleic acid, polysorbate 80, polyvinyl Alcohol, potassium Sorbate, povidone, propylene glycol, sodiummetabisulphite, tartaric acid, trolamine, urea, water

When Using This Product
  • 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.
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
If Pregnant Or Breast Feeding (If Pregnant or Breast Feeding)

ask a health professional before use.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

MAX STRENGTH LIDOCAINE  PATCH

-NUMBS AWAY PAIN

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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