ICE QUAKE PLUS- methyl salicylate, menthol, camphor 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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Active Ingredients               Purpose

Methyl Salicylate  10%      Topical Analgesic

Menthol 10%                    Topical Analgesic

Camphor 3.1%                 Topical Analgesic

Purpose

Topical Analgesic

Uses

temporarily relieves minor pain associated with

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 right away.

Directions

Inactive ingredients: HPMC, glycerin, FD&C Blue No.1, carbopol, isopropyl alcohol, propylene glycol, methylparaben, sodium hydroxide, water

SSS Group, LLC Miami, Fl 33183

icequakeplus

ICE QUAKE  PLUS
methyl salicylate, menthol, camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-266
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53113-266-04113 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: f7c673c3-0b90-48b7-8b40-39179f3b79d8
Set id: 2a7af445-83f2-4da3-8df0-51bd808f8612
Version: 1
Effective Time: 20130927
 
Gadal Laboratories Inc