RUGBY PAIN RELIEVING ANALGESIC (MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE) CREAM [RUGBY LABORATORIES]

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RUGBY PAIN RELIEVING ANALGESIC (MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE) CREAM [RUGBY LABORATORIES]
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NDC 0536-1101-45
Set ID 4c11876c-57ec-4429-a8c4-fb95baa4074a
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories
Generic Name
Product Class
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Menthol 1.0%Topical Analgesic
    Methyl Salicylate 15.0%Topical Analgesic
  • Use

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

    ♦
    arthritis
    ♦
    simple backache
    ♦
    strains
    ♦
    sprains
  • Warnings

    For external use only

    Do not use

    ♦
    immediately after shower or bath
    ♦
    with a heating pad
    ♦
    on wounds, damaged, broken or irritated skin

    When using this product

    ♦
    use only as directed
    ♦
    do not swallow
    ♦
    do not bandage tightly
    ♦
    avoid contact with eyes and mucous membranes

    Stop and ask a doctor if

    ♦
    skin redness or irritation develops
    ♦
    condition worsens or pain lasts for more than 7 days

    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 right away.

  • Directions

    ♦
    adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
    ♦
    children under 12 years: ask a doctor.
  • Other information

    Store at room temperature 15° - 30°C (59°F – 86°F).

  • Inactive ingredients

    Carbomer, Cetearyl Alcohol, Dimethicone, Glycerin, Methylparaben, Polysorbate 60, Propylparaben, Sodium Hydroxide, Sodium Lauryl Sulfate, Water

  • Questions or comments?

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

    NDC 0536-1101-45

    Rugby®
    MAXIMUM STRENGTH

    PAIN RELIEVING
    CREAM

    Net Wt 3 oz (85 g)

    PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    RUGBY PAIN RELIEVING   ANALGESIC
    menthol, unspecified form and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 mg  in 1 mL
    Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Glycerin (UNII: PDC6A3C0OX)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1101-451 in 1 CARTON05/11/2016
    185 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/11/2016
    Labeler - Rugby Laboratories (079246066)
    Registrant - Garcoa, Inc. (103039178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa, Inc.036464697MANUFACTURE(0536-1101)
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