RUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]

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RUGBY ICE BLUE EXTERNAL ANALGESIC (MENTHOL) GEL [RUGBY LABORATORIES, INC.]
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NDC 0536-1061-39
Set ID 2b65cb6a-4364-4770-b7b9-5c4637edd01a
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 2.0%

  • Purpose

    Pain relieving gel

  • Uses

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

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

    For external use only

    Do not use

    • with other topical pain relievers.
    • with heating pads or other heating devices.

    When using this product

    • do not use in or near the eyes.
    • do not apply to wounds or damaged skin.
    • do not bandage tightly.

    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.
    • redness or irritation develops.

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

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

  • Directions

    • Clean affected area before applying product.
    • 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 a doctor.
  • Other information

    • store at room temperature 20 to 25°C (68 to 77°F)
    • Keep lid tightly closed.
    • Do not use, pour, spill or store near heat or open flame.
  • Inactive ingredients

    ammonium hydroxide, blue 1, carbomer, copper sulfate, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water

  • Questions or comments?

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    Distributed by: Rugby Laboratories
    31778 Enterprise Drive
    Livonia, MI 48150

  • PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label

    Rugby® NDC 0536-1061-39

    Blue Gel
    External Analgesic
    Pain Relieving Gel for Minor
    Aches and Pains of Muscles
    and Joints

    COMPARE TO ACTIVE INGREDIENT
    IN MINERAL ICE®*

    NET WT 8 OZ
    (226.8 g)

    PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label
  • INGREDIENTS AND APPEARANCE
    RUGBY ICE BLUE   EXTERNAL ANALGESIC
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1061
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ammonia (UNII: 5138Q19F1X)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    Cupric Sulfate (UNII: LRX7AJ16DT)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Magnesium Sulfate Anhydrous (UNII: ML30MJ2U7I)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Thymol (UNII: 3J50XA376E)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1061-39226.8 g in 1 JAR; Type 0: Not a Combination Product01/20/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34801/20/2015
    Labeler - Rugby Laboratories, Inc. (079246066)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa, Inc.036464697MANUFACTURE(0536-1061)
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