Label: RUGBY ICE BLUE EXTERNAL ANALGESIC- menthol, unspecified form gel

  • NDC Code(s): 0536-1061-39
  • Packager: Rugby 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 January 12, 2022

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

  • 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 (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)