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  5. Label Information: Gadaderm Frozen Ice Advance Pain Relief

FDA Label for Gadaderm Frozen Ice Advance Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. INACTIVE INGREDIENT
    3. KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. DOSAGE & ADMINISTRATION
    7. PURPOSE

Gadaderm Frozen Ice Advance Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Gadal Laboratories, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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