RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]

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RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]
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NDC 0536-2525-25
Set ID c5915c84-84a2-46f6-9f97-0d9873e9944a
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 0.025%

  • Purpose

    External 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 the 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 use 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.

  • 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° - 86°F)

  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, cetyl acetate, methylparaben, PPG-20 methyl glucose ether distearate, propylene glycol, propylparaben, stearate-100, stearic acid, stearyl alcohol, triethanolamine, water

  • Questions or comments?

    Call 1-800-645-2158 9 am - 5 pm ET, Monday - Friday

  • SPL UNCLASSIFIED SECTION

    Mfd for:
    Rugby Laboratories, Inc.
    Duluth, Georgia 30097

  • PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

    NDC 0536-2525-25

    Rugby®

    SATISFACTION GUARANTEED
    Rugby
    OR YOUR MONEY BACK

    Capsaicin Cream, 0.025%

    External Analgesic
    Penetrating Pain Relief

    Net Wt 2.1 oz (60 g)

    PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    RUGBY CAPSAICIN   EXTERNAL ANALGESIC
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-2525
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    Cetyl Acetate (UNII: 4Q43814HXS)  
    Methylparaben (UNII: A2I8C7HI9T)  
    PPG-20 Methyl Glucose Ether Distearate (UNII: 0057334FAB)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Steareth-100 (UNII: 4OH5W9UM87)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Trolamine (UNII: 9O3K93S3TK)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-2525-251 in 1 CARTON03/01/2012
    160 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 FINALpart34803/01/2012
    Labeler - Rugby Laboratories (079246066)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries, Inc.255106239MANUFACTURE(0536-2525)
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