Label: CAPSAICIN 0.025% patch

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

Drug Label Information

Updated August 8, 2025

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  • Active Ingredient

    Capsaicin 0.025% w/w

  • Purpose

    External analgesic

  • Uses

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

    • simple backache
    • arthritis
    • stratins
    • bruises
    • sprains
  • Warnings

    For external use only

  • Do not use

    • On wounds or damaged skin
    • With a heating pad
    • If you are allergic to any ingredients of this product
  • When using this product

    • Use only as directed
    • Avoid contact with the eyes, mucous membranes or rashes
    • Do not bandage tightly
  • Stop use and ask a doctor if

    • Rash, itching or excessive skin irratation develops
    • Condition worsen
    • Symptoms persist for more than 7 days
    • Symptoms clear up and occur again within a few days
  • If pregnant or breast-feeding,

    Ask a health professional before use

  • Keep out of reach of children.

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

  • Directions

    Adult and Children 12 years of age and over:

    • Clean and dry affected area
    • Remove film from patch and apply to the skin
    • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
    • Remove patch from the skin after at most 8-hour application

    Children under 12 years of age:Consult a doctor

  • Other information

    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture
  • Inactive Ingredients

    Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Isopropyl Myristate, Polysorbate 80, PVP, Hydroxyacetophenone, Dihydroxyaluminum Aminoacetate, L-Tartaric Acid, Titanium Dioxide, Carboxymethylcellulose Sodium, Kaolin, Edetate Disodium.

  • Questions or Comments

    Call toll free (307) 410-3813 or info@marcellahealth.com

  • Drug Facts

    Capsaicin 0.025% Patch #30

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN 0.025% 
    capsaicin 0.025% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80425-0541(NDC:85096-401)
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN2.5 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    KAOLIN (UNII: 24H4NWX5CO)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0541-130 in 1 BOX08/08/2025
    110 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/08/2025
    Labeler - Advanced Rx of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx of Tennessee, LLC117023142repack(80425-0541)
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