Label: RUGBY CAPSAICIN CREAM- 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 February 17, 2020

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

  • Drug Facts

  • Active Ingredient

    Capsaicin 0.1%

  • Purpose

    Topical Analgesic

  • Warnings

    For external use only: TEST FIRST ON SMALL AREA OF SKIN.

    When using this product:

    • Use only as directed
    • Do not apply to wounds, damaged, broken or irritated sin
    • Do not use if you are allergic to capssicum or chili peppers
    • Avoid contact with the eyes or mucous membranes
    • A slight burning sensation may occur upon application, but generally disappears after several days of use
    • If severe burning occurs, discontinue use
    • Do not expose the treated area to heat or direct sunlight
    • Do not bandage
    • Do not use with heating pad
  • Stop Use and Ask Doctor

    Stope Use and Ask Doctor if:

    • Condition worsens
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
    • Redness is present
    • irritation develops
  • Keep Out of the Reach of Children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:

    • Arthritis
    • Simple Backache
    • Strains
    • Sprains
    • Bruises
  • If Pregnant or Breast Feeding

    Ask a doctor before use

  • Directions

    Adults and Children over 18 years:

    • Apply to affected area
    • Massage into the painful area until thoroughly absorbed
    • Repeat as necessary but not more than 3 to 4 times daily
    • WASH HANDS WITH SOAP AND WATER AFTER APPLYING

    Children 18 years and younger:

    Ask a doctor

  • Inactive Ingredients

    Aloe barbadensis leaf juice, Ethylparaben, Glycerin, Clyceryl monostearate, Mineral Oil, Octadecyl alcohol, Petrolatum, Purified Water, Sodium lauryl Sulfate

  • Questions

    Call 1-800-645-2158

    Distributed By:

    RUGBY®LABORATORIES

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152

    www.rugbylaboratories.com

    Made in China

  • Other Information

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

  • Packaging

    Capsaicin Cream

  • INGREDIENTS AND APPEARANCE
    RUGBY CAPSAICIN CREAM 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1264
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1264-561 in 1 BOX02/17/2020
    142.5 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 finalpart34802/17/2020
    Labeler - Rugby Laboratories (079246066)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)