ICE QUAKE MUSCLE RUB- 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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Active Ingredients               Purpose

Menthol 2.0%                    Topical Anagesic

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

Warnings

For external use only

When using this product

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

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

Directions

Inactive ingredients carbomer, propylene glycol, methylparaben, isopropyl alcohol, triethanolamine, FD&C Blue #1, water

SSS Grou, LLC Miami, Fl 33183

icequake

ICE QUAKE  MUSCLE RUB
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53113-108-08228 g in 1 JAR
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: 3a135d16-cb5f-4ec6-815f-9993a96763cb
Set id: 8ec2d086-67d8-4a2b-af0d-2d4bb6acce09
Version: 1
Effective Time: 20130916
 
Gadal Laboratories Inc