Laboflex Lidocaine Pain Relieving Patch - Lidocaine 4%

Laboflex Lidocaine Pain Relieving Patch - Lidocaine 4%
SPL v1
SPL
SPL Set ID 2a3c23ed-e850-1390-e063-6294a90a637f
Route
TOPICAL
Published
Effective Date 2025-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Water Glycerin Carboxymethylcellulose Sodium, Unspecified Form Propylene Glycol Tartaric Acid Urea Polysorbate 80 Polyacrylic Acid (250000 Mw) Sodium Polyacrylate (2500000 Mw) Titanium Dioxide Dihydroxyaluminum Aminoacetate Anhydrous Methylparaben Edetate Sodium Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-10

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

Uses

For the temporary relief of pain

Warning

For external use only

Do Not Use

Do not use:

  • On wounds or damaged skin
  • With a heantig pad
  • If you are allergic to any ingredients of this product
Directions:

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: do not use, consult a physiciacn.

  • clean and dry affected area
  • remove the film from the patch and apply to the affected area
  • Use 1 patch at a time and not more than 3 to 4 times daily.
  • Remove patch from the skin after at most 8 hours application

Active Ingredient

Lidocaine 4%

Other Information

Other Information:

  • Do not use if the pouch is opened or damaged
  • Tighlty reseal the pouch containing unused patches
  • Store at room temperature
  • Do not freeze
Inactive Ingredients

Carboxymethylcellulose sodium, Dihydroxyaluminum aminoacetate, Edetate sodium, Glycerin, Lidocaine, Urea, Methyl paraben, Partially neutralized Sodium Polyacrylate, Polyacrylic acid, Polysorbate 80, Propyl paraben, Propylene glycol, Sodium Polyacrylate, Tartaric acid, Titanium dioxide, Water.

Principal Display Panel

When Using This Product

When using the product:

  • use only as directed.
  • do not bandage tightly
  • Avoid contact with the eyes, mucous membranes or rashes
  • do not apply to open wounds or damaged skin
Stop Use and Ask A Doctor If

Stop use and ask doctor if:

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Severe burning sensation, redness or irritation developss
  • 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.

Keep Out of Reach of Children

Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

For the temporary relief of pain

Purpose

Topical anesthetic

Warning

For external use only

Do Not Use (Do not Use)

Do not use:

  • On wounds or damaged skin
  • With a heantig pad
  • If you are allergic to any ingredients of this product
Directions:

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: do not use, consult a physiciacn.

  • clean and dry affected area
  • remove the film from the patch and apply to the affected area
  • Use 1 patch at a time and not more than 3 to 4 times daily.
  • Remove patch from the skin after at most 8 hours application

Active Ingredient (Active ingredient)

Lidocaine 4%

Other Information (Other information)

Other Information:

  • Do not use if the pouch is opened or damaged
  • Tighlty reseal the pouch containing unused patches
  • Store at room temperature
  • Do not freeze
Inactive Ingredients (Inactive ingredients)

Carboxymethylcellulose sodium, Dihydroxyaluminum aminoacetate, Edetate sodium, Glycerin, Lidocaine, Urea, Methyl paraben, Partially neutralized Sodium Polyacrylate, Polyacrylic acid, Polysorbate 80, Propyl paraben, Propylene glycol, Sodium Polyacrylate, Tartaric acid, Titanium dioxide, Water.

Principal Display Panel

When Using This Product

When using the product:

  • use only as directed.
  • do not bandage tightly
  • Avoid contact with the eyes, mucous membranes or rashes
  • do not apply to open wounds or damaged skin
Stop Use and Ask A Doctor If (Stop Use and Ask a Doctor if)

Stop use and ask doctor if:

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Severe burning sensation, redness or irritation developss
  • 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)

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


Advanced Ingredient Data


Raw Label Data

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