Label: ICE QUAKE ANALGESIC CREAM WHITE- methyl salicylate and menthol cream

  • 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 October 30, 2009

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  • Active Ingredients

    Methyl Salicylate 8%

    Menthol 2%

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints due to:

    • arthritis
    • simple backache
    • bruises
    • strains
    • sprains
  • Warnings

    For external use only.

    If pregnant or breast-feeding, ask a health professional before use.

  • When using this product

    • use only as directed
    • Avoid contact with eyes and mucous membranes
    • do not bandage tightly or use with a heating devices
    • do not apply to wounds or damaged skin
    • Do not apply to irritated skin
  • 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 12 Years of Age or Older

    • Apply generously to affected area
    • Massage into painfil area until thoroughly absorbed into skin
    • Repeat as necessary, but no more than 3 to 4 times daily
  • INACTIVE INGREDIENT

    Mineral oil, Propylene glycol, Cetyl stearyl alcohol, Purified water, Ceteareth-6, Stearyl alcohol, PEG-20 Cetyl/Stearyl Ether, Methylparaben, propylparaben.

  • PRINCIPAL DISPLAY PANEL

    Analgesic Cream White

    MENTHOL 2%, METHYL SALICYLATE 8%

    NET WT 2 OZ (60 g)

    Store: At Room Temperature 15° - 30°C (59°- 86°F). Close cap tightly after use.

    ICE QUAKE WHITE


    Distribute By: SSS group, LLC

    Pembroke Pines, FL 33332

    Questions or Commnets?

    Call 800.213.9370

  • INGREDIENTS AND APPEARANCE
    ICE QUAKE ANALGESIC CREAM WHITE 
    methyl salicylate and menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE8.0 
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.0 
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    CETEARETH-6 (UNII: 2RJS3559D3)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69822-300-021 in 1 TUBE; Type 0: Not a Combination Product10/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2016
    Labeler - Southern Sales & Service, Inc. (013114906)
    Establishment
    NameAddressID/FEIBusiness Operations
    Southern Sales & Service, Inc.013114906LABEL(69822-300)
    Establishment
    NameAddressID/FEIBusiness Operations
    GADAL Laboratories, Inc841305639MANUFACTURE(69822-300)
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