Label: RUGBY CAPSAICIN CREAM- capsaicin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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

    Stop 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 (1-800-222-1222) 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, Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monostearate, Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Purified Water, stearic acid.

  • Questions

    Call 1-800-645-2158

    Distributed By:

    RUGBY®LABORATORIES

    Livonia, MI 48152

    www.rugbylaboratories.com

    rev. 09/21 R-167 Re-order No. 370818

  • Other Information

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

  • Packaging

    5882244 CAH RGB Capsaicin Cream 42.5g CDER

  • 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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LAURETH-15 (UNII: 002FR4N8OV)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    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 DrugM01702/17/2020
    Labeler - Rugby Laboratories (079246066)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)