Label: CAPSAICIN PAIN RELIEF- capsaicin patch

  • NDC Code(s): 67510-0303-1, 67510-0303-2
  • Packager: Kareway Product, 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 June 7, 2018

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  • Active ingredient

    Capsicum extract 0.025% as Capsaicin

  • Purpose

    Topical analgesic

  • Uses

    For temporary relief of minor aches and pains of muscles and joints associated with:

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

    For external use only.

    Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower.

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • with, or at the same times as other external analgesic products
    • if you are allergic to any ingredients of this product

    When using this product

    • use only as directed
    • avoid contact with the eyes, mucous membranes or rashes

    Stop use and ask a doctor if

    • rash, itching or excessive skin irritation develops
    • conditions worsen
    • symptoms persist for more than 7 days
    • symptoms 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 of age and over:

    • Clean and dry affected area
    • Remove patch from film
    • Apply to affected area not more than 3 to 4 times daily for 7 days
    • Remove patch from the skin after at most 8 hour's application

    Children under 12 years of age:

    • Consult a doctor


  • Other information

    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture
  • Inactive ingredients

    hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

  • Package label

    Capsaicin Hot Patch

    label

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN PAIN RELIEF 
    capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.702 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    LIQUID PETROLEUM (UNII: 6ZAE7X688J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0303-11 in 1 CARTON01/23/2012
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:67510-0303-22 in 1 POUCH; Type 0: Not a Combination Product05/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/23/2012
    Labeler - Kareway Product, Inc. (121840057)
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