Label: PAINBLOC24- capsaicin 0.25% solution

  • 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 January 4, 2022

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  • Active Ingredient

    Capsaicin 0.25%

  • Purpose

    Topical Analgesic

  • Uses

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

    • Arthritis
    • Simple backache
    • Muscle strains
    • Bruises
    • Sprains
  • Warnings

    For external use only

    When using this product

    • Use only as directed
    • Do not bandage tightly or cover treated area
    • Do not use with heating pad
    • Avoid contact with eyes and mucous membranes
    • Do not apply to wounds, damaged, broken or irritated skin
    • Do not expose the area treated with product to heat or direct sunlight
    • If using before exercise, showering or swimming, apply, wait 30 minutes, then wash off before participating
    • A temporary burning sensation and/or redness may occur upon application. This is normal and generally stops after a few days of use

    Stop use and ask a doctor if

    • Severe burning sensation occurs
    • You experience difficulty breathing or swallowing
    • Condition worsens
    • Redness persists, spreads or becomes tender
    • Irritation develops
    • Symptoms last more than 7 days or clear up and occur again within a few days

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

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

  • Directions

    Adults over 18 years:

    • Apply by holding Pain Pen straight down and press tip repeatedly on to affected area until liquid flows. Then dab sparingly.
    • Allow to dry
    • Repeat application, as needed, every 12 to 24 hours
    • Do not use more than twice a day
    • Wash hands with soap and water after each application. If applying to hand, wait 30minutes, then wash with soap and cold water after each application.
    • If soap does not completely remove all product residues, try using skin or mineral oil.
    • May take several days to reach full effect
  • Inactive Ingredients

    Alcohol, Diethylene Glycol Monoethyl Ether, Hyaluronate Sodium, Polysorbate 80, Pramoxine HCl, Propylene Glycol, Water

  • Questions

    Call 855-438-3944

  • SPL UNCLASSIFIED SECTION

    Distributed by Vizuri Consumer Healthcare
    Fairfax, VA 22033 U.S.A.

  • PRINCIPAL DISPLAY PANEL - 12 mL Bottle Carton

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  • INGREDIENTS AND APPEARANCE
    PAINBLOC24 
    capsaicin 0.25% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71226-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71226-001-061 in 1 CARTON11/05/2019
    112 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/05/2019
    Labeler - Vizuri Health Sciences LLC (052129499)
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