Gadaderm Frozen Ice Advance Pain Relief
FDA Label NDC 53113-362

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gadal Laboratories, Inc for the product Gadaderm Frozen Ice Advance Pain Relief (NDC 53113-362). 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 ingredients, inactive ingredient, keep out of reach of children, indications & usage, warnings, dosage & administration, purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Active IngredientsPurpose
Methyl Salicylate 10%Topical Analgesic
Menthol 10%Topical Analgesic
Camphor 3.1%Topical Analgesic

Inactive Ingredient

Carbopol, Cetearyl Alcohol, Disodium EDTA, FD&C Blue #1, Glycerin, Hydroxypropyl Methylcellulose, Menthylparaben, Propylene Glycol, Propylparaben, Polysorbate 20, Purified Water, Stearic Acid, Sodium Hydroxide.

Keep Out Of Reach Of Children

Indications & Usage

Warnings

For the external use only. When using this product use as directed.

  • Do not bandage tightly or use with heating pad. Avoid contact with eyes and mucous membranes.
  • Do not apply to wounds or damaged, broken, or irritated skin.
  • If severe burning sensation occurs, discontinue use immediately.
  • Do not expose the area treated with product to heat or direct sunlight.
  • Stop use and ask a doctor if conditions worsen, redness is present, irritation develops.

    • If swallowed, get medical help or contact a Poison Control Center right away. IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

Dosage & Administration

Adults and children 12 years of age and older; apply generously to affected area massage into painful area until thoroughly absorbed into skin. Repeat as necessary but not more than 3 to 4 times daily.

Purpose

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.

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