Ice Quake
FDA Label NDC 53113-100

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 Ice Quake (NDC 53113-100). 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 other, active ingredient, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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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)

Principal Display Panel (113 g Tube Label)

Principal Display Panel (113 g Tube Label)

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