Label: ICE QUAKE MUSCLE RUB- menthol gel

  • Category: HUMAN OTC DRUG LABEL

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 16, 2013

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  • ACTIVE INGREDIENT

    Active Ingredients               Purpose

    Menthol 2.0%                    Topical Anagesic

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
    • sport injuries
  • WARNINGS

    Warnings

    For external use only

    When using this product

    • avoid contact with the eyes
    • do not bandage tightly
    • do not apply to wounds or damaged skin
    • do not use with heating pads or ther heating devices

    Stop use and ask a doctor if

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily.
    • children under 2 years of age; do not use, consult doctor
  • INACTIVE INGREDIENT

    Inactive ingredients carbomer, propylene glycol, methylparaben, isopropyl alcohol, triethanolamine, FD&C Blue #1, water

  • QUESTIONS

    SSS Grou, LLC Miami, Fl 33183

  • PRINCIPAL DISPLAY PANEL

    icequake

  • INGREDIENTS AND APPEARANCE
    ICE QUAKE  MUSCLE RUB
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53113-108-08228 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2013
    Labeler - Gadal Laboratories Inc (841305639)
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