Label: ICE QUAKE- menthol gel

  • NDC Code(s): 69822-100-04
  • Packager: Southern Sales & Service, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Menthol 15%

  • Purpose

    Topical Analgesic

  • Uses

    For temporary relief of minor pain associated with:

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

     Avoid contact with eyes. For external use only.

    When using this product

    • do not bandage tightly 
    • do not apply to wounds or damaged skin.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    apply to affected area not more than 3 to 4 tmes daily. Adults and children 18 years of age and older:

    consult a doctor. Children under 18 years of age:

  • Inactive ingredients

    glycerine, FD&C blue no. 1, carbopol, hydroxypropyl methylcellulose, isopropyl alcohol, propylene glycol, methylparaben, sodium hydroxide, purified water.

  • IceQuake Pain Relieving Gel 113g

    IceQuake Pain Relieving Gel 4 oz 113g

  • INGREDIENTS AND APPEARANCE
    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) MENTHOL0.15 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69822-100-04113 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 DrugM01701/04/2015
    Labeler - Southern Sales & Service, Inc. (013114906)
    Registrant - Southern Sales & Service, Inc. (013114906)
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