Label: CAPSAICIN CREAM- capsaicin cream

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

Drug Label Information

Updated December 28, 2023

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 skin
    • Do not use if you are allergic to capsicum 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
    • 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
    • Do not use at the same time as other topical analgesics
  • 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
    • You experience signs of skin injury such as pain, swelling or blistering.
  • 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, Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monostearate, Mineral Oil, Petrolatum, Purified Water, Polyoxyethylene Lauryl Ether, Stearic Acid

  • Other Information

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

    This product is not manufactured or distributed by Chattem, distributor of Capzaicin-HP arthritis pain relief.

  • Questions

    Questions or Comments

    Please call Toll Free 1-888-296-9067

  • Other Information

    Manufactured for

    Noble OTC LLC

    Perth Amboy, NJ 08861

    www.nobleotc.com

    This product is not manufactured or distributed by Chattem, a distributor of Capzaicin-HP Arthritis Pain Relief

  • PRINCIPAL DISPLAY PANEL

    Noble Capsaicin Cream 1.5oz CDER

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN CREAM 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81533-200
    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
    LAURETH-23 (UNII: N72LMW566G)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81533-200-151 in 1 BOX07/14/2022
    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 DrugM01707/14/2022
    Labeler - Noble OTC LLC (041836435)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)