Puregen Labs Pain Relief 4 Lidocaine Patch
FDA Label NDC 80513-814

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Puregen Labs Pain Relief 4 Lidocaine (NDC 80513-814). 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 drug facts, active ingredient, purpose, uses:, warnings:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Lidocaine 4.00 %

Purpose

Topical Anesthetic

Uses:

  • For the temporary relief of pain.

Warnings:

For external use only.

Do Not Use

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • If you are allergic to any ingredients of this product

When Using This Product

  • Avoid contact with the eyes

Stop Use And Ask A Doctor If

  • localized skin reactions occur, such as rash, itching, redness, irritation
  • condition worsens, or if
  • symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children.

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

If Pregnant Or Breast-Feeding,

ask a health professional before use

Directions:

  • Adults andchildren 12 years of age and older:
  • Clean and dry the affected area
  • Apply a patch at a time to the affected area; not more than 3 or 4 times daily to the affected area
  • Remove the patch from the skin after at most 8 hours of application
  • Children under 12 years of age: consult a doctor.

Other Information:

  • Store at 20-25°C (68-77°F) and protect from moisture.

Inactive Ingredients

Aqua (Deionized Water), Dihydroxyaluminum Aminoacetate, Disodium EDTA, Glycerin, Methylparaben, Polyvinyl Alcohol, Propylene Glycol, Propylparaben, Sodium Carboxymethyl Cellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

Questions?

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