Ice Quake

Ice Quake

Drug Labeling and Warnings

Drug Details

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ICE QUAKE- menthol gel 
Southern Sales & Service, 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:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises
  • cramps

Warnings

For external use only.

When using this product

  • Use only as directed
  • Do not bandage tightly 
  • Do not use with a heating devices
  • Avoid contact with eyes and mucous membranes
  • Do not apply to wounds, 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:

  • 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.

Distribute By:


SSS Group, LLC

Pembroke Pines

FL 33332

Questions or Comments

Call 1 800.213.9370

ICE QUAKE (MENTHOL)

Label Image
ICE QUAKE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69822-100
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: 69822-100-04 113 g in 1 JAR; Type 0: Not a Combination Product01/04/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34808/23/2012
Labeler - Southern Sales & Service, Inc. (013114906)
Establishment
NameAddressID/FEIBusiness Operations
Southern Sales & Service, Inc.013114906LABEL(69822-100)
Establishment
NameAddressID/FEIBusiness Operations
GADAL Laboratories, Inc841305639MANUFACTURE(69822-100)

Revised: 1/2017
 
Southern Sales & Service, Inc.


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