Label: RUGBY CAPSAICIN EXTERNAL 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 December 28, 2020

If you are a consumer or patient please visit this version.

  • 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)