RUGBY ARTHRITIS PAIN RELIEVING TOPICAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES]

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RUGBY ARTHRITIS PAIN RELIEVING TOPICAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES]
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NDC 0536-1118-25
Set ID 8f1bc075-97ac-4154-8768-0d878104c3ba
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

    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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