ICE QUAKE WHITE- methyl salicylate, menthol cream 
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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Active Ingredients               Purpose

Methyl Salicylate  8%      Topical Analgesic

Menthol 2%                    Topical Analgesic

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints due to

Warnings

For external use only

When using this product: Use only as directed

Stop use and ask a doctor if

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions

Inactive ingredients: mineral oil, propylene glycol, cetyl stearyl alcohol, purified water, ceteareth-6, stearyl alcohol, PEG-20 Cetyl/stearyl ether, methylparaben, propylparaben

SSS Group, LLC Miami, Fl 33183

icequakewhite

ICE QUAKE  WHITE
methyl salicylate, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-688
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
WATER (UNII: 059QF0KO0R)  
CETEARETH-6 (UNII: 2RJS3559D3)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53113-688-0560 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2013
Labeler - Gadal Laboratories Inc (841305639)

Revised: 9/2013
Document Id: 6720c67b-21f5-485d-90e1-c40bad7dd1f6
Set id: 700b3dab-0b6c-44ea-8866-e9cffa81fc0e
Version: 1
Effective Time: 20130920
 
Gadal Laboratories Inc