Label: RUGBY ARTHRITIS PAIN RELIEVING TOPICAL ANALGESIC- capsaicin 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 12, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Capsaicin 0.075%

  • Purpose

    Topical Analgesic

  • Uses

    temporarily relieves minor aches and pains of muscles and joints due to:

    ♦
    simple backache
    ♦
    arthritis
    ♦
    strains
    ♦
    sprains
  • Warnings

    For external use only

    Read all warnings and directions before use. TEST FIRST ON SMALL AREA OF SKIN.

    Do not use

    ♦
    on wounds or damaged skin
    ♦
    if you are allergic to capsicum or chili peppers

    When using this product

    ♦
    you may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
    ♦
    avoid contact with eyes, lips, nose and mucous membranes
    ♦
    do not tightly wrap or bandage the treated area
    ♦
    do not apply heat to the treated area immediately before or after use

    Stop and ask a doctor if

    ♦
    condition worsens or does not improve after regular use
    ♦
    severe burning persists or blistering occurs

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

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

  • Directions

    Adults and children 18 years of age and older:

    ♦
    apply a thin film of cream to affected area and gently rub in until fully absorbed
    ♦
    unless treating hands, wash hands thoroughly with soap and water immediately after application
    ♦
    for best results, apply 3 to 4 times daily.

    Children under 18 years: ask a doctor

  • Other information

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

  • Inactive ingredients

    benzyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl myristate, PEG-100 stearate, petrolatum, sorbitol, water

  • Questions or comments?

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    Distributed by: Rugby Laboratories
    17177 N Laurel Park Dr., Suite 233
    Livonia, MI 48152

  • PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

    NDC 0536-1118-25

    Rugby ®

    COMPARE TO
    ZOSTRIX® HP
    ACTIVE INGREDIENT*

    HIGH POTENCY
    ARTHRITIS PAIN RELIEVING CREAM
    0.075% CAPSAICIN TOPICAL ANALGESIC

    Odor Free Formula • Clinically Tested Active Ingredient
    Net Wt 2 oz (57 g)

    PRINCIPAL DISPLAY PANEL - 57 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    RUGBY ARTHRITIS PAIN RELIEVING   TOPICAL ANALGESIC
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.75 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1118-251 in 1 CARTON05/24/2017
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34805/24/2017
    Labeler - Rugby Laboratories (079246066)
    Registrant - Garcoa, Inc (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa, Inc036464697MANUFACTURE(0536-1118)
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