Label: CAPSAICIN patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 30, 2022

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  • SPL UNCLASSIFIED SECTION

    CAPSAICIN – Capsaicin 0.025% Patch

    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.

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    Capsaicin 0.025% Patch


    Drug Facts

  • Active ingredient

    Capsaicin 0.025%

  • Purpose

    External analgesic

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints due to:

    • arthritis

    • simple backache

    • strains

    • bruises

    • sprains

  • Warnings

    For external use only. Use only as directed or as directed by a health care professional

    Read all warnings and directions before use.

    Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming.

    Do not use

    • On wounds, cuts, damaged or infected skin

    • On eyes, mouth, genitals, or any other mucous membranes

    Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use.

    When using this product

    • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.

    • Avoid contact with the eyes, lips, nose and mucous membranes

    • Do not tightly wrap or bandage the treated area

    • Do not apply heat to the treated area immediately before or after use

    Stop use and ask a physician:

    • If pregnant or breast feeding

    • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

    • If severe burning persists or blistering occurs

    Keep out of reach of children and pets.

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

  • Directions

    Adults and children 18 years of age and older:

    Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.

    • Clean and dry the affected area.
    • Open pouch and remove one patch.
    • Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.
    • Wash hands with soap and water after handling the patches.
    • Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
    • Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.

    Children under 18 years: Ask a physician

  • Other information

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

  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    NDC 81877-515-15

    Qty: 15 Patches
    (5 per Resealable Pouch) x 3

    Capsaicin 0.025%
    Topical Pain Patch
    for temporary pain relief

    Forreal Pharmaceuticals LLC

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN 
    capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81877-515
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    KAOLIN (UNII: 24H4NWX5CO)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TARTARIC ACID (UNII: W4888I119H)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81877-515-1515 in 1 CARTON08/16/2022
    1100 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/16/2022
    Labeler - FORREAL PHARMACEUTICALS LLC (118029197)
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