Label: ICE QUAKE WHITE- methyl salicylate, menthol cream

  • NDC Code(s): 53113-688-05
  • Packager: Gadal Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated September 20, 2013

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients               Purpose

    Methyl Salicylate  8%      Topical Analgesic

    Menthol 2%                    Topical Analgesic

    Close
  • PURPOSE

    Purpose

    Topical Analgesic

    Close
  • INDICATIONS & USAGE

    Uses

    For the temporary relief of minor aches and pains of muscles and joints due to

    • arthritis
    • simple backache
    • strains
    • bruises
    • sprains
    Close
  • WARNINGS

    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
    Close
  • KEEP OUT OF REACH OF CHILDREN

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

    Close
  • DOSAGE & ADMINISTRATION

    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. 
    Close
  • INACTIVE INGREDIENT

    Inactive ingredients: mineral oil, propylene glycol, cetyl stearyl alcohol, purified water, ceteareth-6, stearyl alcohol, PEG-20 Cetyl/stearyl ether, methylparaben, propylparaben

    Close
  • QUESTIONS

    SSS Group, LLC Miami, Fl 33183

    Close
  • INGREDIENTS AND APPEARANCE
    ICE QUAKE  WHITE
    methyl salicylate, menthol cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53113-688
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 8 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    CETEARETH-6 (UNII: 2RJS3559D3)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53113-688-05 60 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/01/2013
    Labeler - Gadal Laboratories Inc (841305639)
    Close