Label: CAPSAICIN CREAM- capsaicin cream

  • NDC Code(s): 69396-103-02
  • Packager: Trifecta Pharmaceuticals USA LLC
  • 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 August 14, 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
    • 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

    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
    • 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

    Distributed by

    Trifecta Pharmaceuticals USA

    101 NE Third Aveue, Suite 1500

    Fort Lauderdale, FL 33301

    www.trifecta-pharma.com

  • PRINCIPAL DISPLAY PANEL

    globe-capsaicin-60g-CDER

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN CREAM 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-103
    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:69396-103-021 in 1 BOX05/14/2022
    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 finalpart34805/14/2022
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)