Label: CAPSIMIDE- capsaicin 0.025% topical patch patch

  • 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 September 7, 2022

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  • Active Ingredients

    Capsaicin 0.025%

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves minor pain.

  • Warnings

    For external use only

  • Do not use

    • more than one patch on your body at a time
    • on cut, irritated or swollen skin
    • on puncture wounds
    • for more than one week without consulting a doctor
    • if you are allergic to any active or inactive ingredients
    • if pouch is damaged or opened
  • When using this product

    • use only as directed
    • read and follow all directions and warnings on this carton
    • do not allow contact with the eyes
    • do not sue at the same time as other topical analgesics
    • do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • do not microwave
    • dispose of used patch in a manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
  • Stop use and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.
  • If pregnant or breast-feeding

    ask a health professional before use.

  • Keep our of reach of children

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

  • Directions

    Adults and children 12 years of age and over: Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch after single use. Children under 12 years of age: consuly a physician.

  • Other Information

    Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

  • Other Ingredients

    Glycerin, Sodium polyacrylate, Dihydroxyaluminum aminoacetate, Edetate disodium, Kaolin, Carboxymethylcellulose sodium, Titanium dioxide, L-Tartaric acid, Polyacrylic acid, Propylene glycol, Polysorbate 80, Isopropyl Myristate, Hydroxyacetophenone, Water, and PVP

  • Questions or comments?

    866-747-7365

  • PRINCIPAL DISPLAY PANEL

    Manufactured for:

    SOLA PHARMACEUTICALS LLC

    Baton Rouge, LA 70810

    www.solameds.us

    Made in China

    Capsimide Patch

    NDC 70512-016-10

    Qty: 10 Patches

    (1 per pouch) x 10

    Capsimide pouch

    Capsimide box

  • INGREDIENTS AND APPEARANCE
    CAPSIMIDE 
    capsaicin 0.025% topical patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70512-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    KAOLIN (UNII: 24H4NWX5CO)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TARTARIC ACID (UNII: W4888I119H)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70512-016-1010 in 1 BOX09/07/2022
    19 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/07/2022
    Labeler - Sola Pharmaceuticals (080121345)
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