Laboflex Lidocaine Pain Relieving Patch
FDA Label NDC 83655-109

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboflex, Inc. for the product Laboflex Lidocaine Pain Relieving Patch (NDC 83655-109). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, inactive ingredients, directions:, keep out of reach of children, if pregnant or breast feeding, stop use and ask a doctor if, when using this product, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Lidocaine 4%

Directions:

Adults and children 12 years of age and older:apply to affected area not more than 3 to 4 times daily.

Children under 12 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

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.

If Pregnant Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

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

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

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

Warning

For external use only

Uses

For the temporary relief of pain

Purpose

Topical anesthetic

Principal Display Panel

Box With 5patches (Lidocaine4 Box 83655 109 15)

Box With 5patches (Lidocaine4 Box 83655 109 15)

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