Label: CAPSIMIDE- capsaicin 0.025% topical patch patch

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

Drug Label Information

Updated January 9, 2024

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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 DrugM01709/07/2022
    Labeler - Sola Pharmaceuticals (080121345)
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