Gerigentle Frostyheat Pain Relief Patch 4 Lodocaine Back Patch
FDA Label NDC 69771-010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geri-gentle Corporation for the product Gerigentle Frostyheat Pain Relief Patch 4 Lodocaine Back (NDC 69771-010). 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, purpose, uses, warnings:, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Uses

For 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 heating pad
  • if you are allergic to any ingredient of this product.

When Using This Product

  • use only as directed
  • avoid contact with eyes and mucous membranes or rashes
  • do not bandage tightly

Stop Use And Ask A Doctor If

  • localized skin reactions, such as rash, itching, redness, pain swelling and blistering develop
  • Condition worsens
  • Symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days.

If Pregnant Or Breast-Feeding,

ask a health care professional before use.

Keep Out Of Reach Of Children And Pets.

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

Directions:

Adults and children over 12 years:

  • Clean and dry affected area.
  • remove film from patch and apply to skin
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily.
  • wear each patch up to 8 hours maximum.
  • Children 12 years or younger: consult a physcian

Other Information:

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive Ingredients:

Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Package Labeling:

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