Label: RUGBY PAIN RELIEVING ANALGESIC- menthol, unspecified form and methyl salicylate cream

  • 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 10, 2022

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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 (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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