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Ice Quake White

Dosage form: cream
Ingredients: MENTHOL 2g in 100g, METHYL SALICYLATE 8g in 100g
Labeler: Gadal Laboratories Inc
NDC Code: 53113-688

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.

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Warnings

For external use only

When using this product: Use only as directed

  • avoid contact with the eyes and mucous membranes
  • do not bandage tightly
  • do not apply to wounds or damaged skin
  • do not use with heating devices
  • do not apply to irritated skin
  • if pregnant or breast feeding, ask a health prodessional before us

Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation develops

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

Directions

  • adults and children 2 years of age and older; apply generously to affected area massage into painful area until thoroughly absorbed into skin. Repeat if necessary but not more than 3 to 4 times daily. 

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

ICE QUAKE  WHITE
methyl salicylate, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-688
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL2 g  in 100 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
PROPYLENE GLYCOL 
CETOSTEARYL ALCOHOL 
WATER 
CETEARETH-6 
STEARYL ALCOHOL 
POLYOXYL 20 CETOSTEARYL ETHER 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
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: 09/2013
 
Gadal Laboratories Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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