Gerigentle Frostyheat Pain Relief Patch Back Patch
FDA Label NDC 69771-012

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 Back (NDC 69771-012). 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, use, 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

Menthol 5%

Purpose

Topical anesthetic

Use

  • Temporarily relieves minor aches and pains of muscles and joints due to
  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises.

Warnings:

For external use only

Do Not Use

  • 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

Stop Use And Ask A Doctor If

  • conditions worsen
  • excessive redness or irritation is present
  • 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 12 years of age and over:Clean and dry affected area.

  • 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 under 12 years of age: consult a physician.

Other Information:

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

Inactive Ingredients:

Glycerin, Sodium polyacrylate, Dihydroxyaluminum Aminoacetate, Methylparaben, Propylparaben, Titanium Dioxide, Kaolin, Polysorbate 80, Propylene Glycol, Tartaric Acid, PVP, Polyacrylic Acid, Water, Petrolatum, CMC, Mineral Oil.

Package Labeling:

Label03 (Label03)

Label03 (Label03)

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