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Ice Quake by Southern Sales & Service, Inc.

Medically reviewed on Jan 4, 2017

Dosage form: gel
Ingredients: MENTHOL 16.95g in 113g
Labeler: Southern Sales & Service, Inc.
NDC Code: 69822-100

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.

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)
ICE QUAKE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL16.95 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
Glycerin 
FD&C Blue NO. 1 
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) 
Sodium Hydroxide 
Water 
Propylene Glycol 
Methylparaben 
Isopropyl Alcohol 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69822-100-04 113 g in 1 JAR
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/FEIOperations
Southern Sales & Service, Inc.013114906LABEL(69822-100)
Establishment
NameAddressID/FEIOperations
GADAL Laboratories, Inc841305639MANUFACTURE(69822-100)

 
Southern Sales & Service, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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