Label: WELLPATCH WARMING PAIN RELIEF- capsaicin patch

  • NDC Code(s): 10742-8127-1, 10742-8127-2
  • Packager: The Mentholatum Company
  • 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 November 1, 2016

If you are a consumer or patient please visit this version.

  • Active ingredient

    Capsaicin 0.025%

  • Purpose

    Capsaicin - Topical analgesic

  • Uses

    temporarily relieves minor aches and pains of muscles and joints due to

    simple backache
    arthritis
    strains
    sprains
  • Warnings

    For external use only

    use only as directed
    do not use at least 1 hours before, or immediately after, a bath or shower
    avoid contact with eyes and mucous membranes
    do not apply to wounds or to damaged or very sensitive skin
    do not bandage tightly or use with a heating pad

    Stop use and ask a doctor if

    condition worsens
    excessive redness, irritation, burning or discomfort of the skin develops
    symptoms persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

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

  • Directions

    adults and children 12 years and over: apply to affected area; change patch 1 to 2 times daily
    children under 12 years: ask a doctor
    FOR BEST RESULTS: apply to clean, dry skin
    tear open pouch and remove patch; if desired, cut patch to size
    grasp both ends of the patch firmly with thumbs near center
    stretch patch until the backing separates
    remove protective film while applying patch directly to site of pain
    WASH HANDS WITH SOAP AND WATER AFTER APPLYING
  • Inactive ingredients

    carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, methylparaben, partially neutralized polyacrylate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, propylene glycol monocaprylate, purified water, sodium polyacrylate, sodium polyacrylate starch, sorbitol solution, talc, tartaric acid

  • Questions or comments?

    Toll free 1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

  • Package/Label Principal Display Panel

    WellPatch Warming Pain Relief Patch

  • Principal Display Panel

    Drug Facts
  • INGREDIENTS AND APPEARANCE
    WELLPATCH WARMING PAIN RELIEF 
    capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8127
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN025 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    PROPYLENE GLYCOL CAPRYLATE (UNII: RT9P9S09QI)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    SORBITOL (UNII: 506T60A25R)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8127-11 in 1 POUCH; Type 0: Not a Combination Product12/05/2016
    2NDC:10742-8127-24 in 1 POUCH; Type 0: Not a Combination Product12/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/05/2016
    Labeler - The Mentholatum Company (002105757)