ICE QUAKE- menthol gel 
Gadal Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Ice Quake

Drug Facts

Active Ingredient

Menthol 15%

PURPOSE

Topical analgesic

Uses

temporarily relieves minor pain associated with:

Warnings

For external use only.

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.

Stop use and ask a doctor if:

  • condition worsens
  • redness is present
  • irritation develops

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:

Inactive Ingredients

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

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

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
ICE QUAKE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol16.95 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Glycerin (UNII: PDC6A3C0OX)  
FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Methylparaben (UNII: A2I8C7HI9T)  
Isopropyl Alcohol (UNII: ND2M416302)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53113-100-01113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34808/23/2012
Labeler - Gadal Laboratories, Inc. (841305639)
Establishment
NameAddressID/FEIBusiness Operations
Gadal Laboratories, Inc.841305639MANUFACTURE(53113-100)

Revised: 9/2012
Document Id: a6f37e88-1493-4c23-8f17-3136964406ca
Set id: 1de1c714-cc53-45dc-a678-b36e59b15184
Version: 1
Effective Time: 20120904
 
Gadal Laboratories, Inc.