FDA Label for Ice Quake

View Indications, Usage & Precautions

Ice Quake 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.

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Drug Facts

MANUFACTURED BY:
GADAL Laboratories, Inc.• Miami, FL 33186


Active Ingredient



Menthol 15%


Purpose



Topical analgesic


Uses



temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings



For external use only.


Otc - When Using



When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or 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.

Otc - Stop Use



Stop use and ask a doctor if:

  • condition worsens
  • redness is present
  • irritation develops

Otc - Keep Out Of Reach Of Children



Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



adults and children over 18 years:

  • apply to affected area
  • squeeze desired amount of ICEQUAKE onto affected area
  • massage dispensed gel into painful area until thoroughly absorbed
  • repeat as necessary, but no more than 3 to 4 times daily.
    • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

Inactive Ingredients



HPMC, Glycerine, FD&C blue #1, Carbopol, Isopropyl alcohol, Propylene glycol, Methylparaben, Sodium hydroxide, Purified water.


Principal Display Panel - 113 G Tube Label



ICEQUAKE
Pain Relieving GEL
Menthol
15%

Net wt 4 oz (113 g)


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