Label: ARTHRITIS PAIN RELIEVER- capsaicin cream

  • NDC Code(s): 59092-001-01, 59092-001-12
  • Packager: HPI Health Products Inc.
  • 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 December 24, 2013

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Capsaicin 0.025%

  • Purpose

    Topical analgesic

  • Uses

    temporarily relieves minor pain of muscles and joints associated with:

    • arthritis
    • simple backache
    • strains
    • sprains
    • bruises
  • Warnings

    • For external use only.

    When using this product

    • use only as directed
    • do not bandage
    • do not use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged, broken or irritated skin
    • a transient burning sensation occurs upon application but generally disappears in several days
    • if severe burning sensation occurs, discontinue use
    • do not expose the area treated with product to heat or direct sunlight
    • do not use if you are allergic to capsaicin or chili peppers

    Stop use and ask a doctor if

    • condition worsens
    • redness if present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breast-feeding, ask a health care professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children over 18 years:

    • apply to affected area
    • massage into painful area until thoroughly absorbed
    • repeat if necessary, but no more than 3 to 4 times daily
    • WASH HANDS WITH SOAP AND WATER AFTER APPLYING
    • Children 18 years and younger: ask a doctor
  • Other information

    • store at 20-25°C (68-77°F)
  • Inactive ingredients

    Abies balsamea, carbomer, cedarwood bark oil, diazolidinyl urea, ethanol, methylparaben, propylene glycol, propylparaben, triethanolamine, water

  • Questions or comments?

    Call us toll-free at (877) 514-3132 between 9am and 4pm (PST), Monday through Friday. Visit us on the website at lakotaherbs.com

  • SPL UNCLASSIFIED SECTION

    distributed by:
    Natural Pain Relief Agency Inc.
    Phoenix, AZ 85086

  • PRINCIPAL DISPLAY PANEL - 88 ml Bottle Carton

    LaKOTA
    Roll-On Pain Reliever

    Arthritis Pain Releiver

    Capsaicin – Topical analgesic

    3 fl.oz/88ml

    Principal Display Panel - 88 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ARTHRITIS PAIN RELIEVER 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59092-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    capsaicin (UNII: S07O44R1ZM) (capsaicin - UNII:S07O44R1ZM) capsaicin0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    canada balsam (UNII: K304VI98I3)  
    alcohol (UNII: 3K9958V90M)  
    carbomer interpolymer type A (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    trolamine (UNII: 9O3K93S3TK)  
    water (UNII: 059QF0KO0R)  
    cedrus atlantica bark oil (UNII: ZX5QRE4U60)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59092-001-121 in 1 CARTON
    1NDC:59092-001-0188 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34801/19/2014
    Labeler - HPI Health Products Inc. (202932864)