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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  • SPL UNCLASSIFIED SECTION

    Drug facts

  • 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 to affected area using roller ball until visibly moist
    • Allow to dry
    • Repeat application, as needed, every 12 to 24 hours
    • Do not use more than a twice a day
    • Wash hands with soap and water after each application
    • May take several days to reach full effect
  • Inactive Ingredients

    Alcohol, Diethylene Glycol Monoethyl Ether, Hyaluronate Sodium, Polysorbate 80, 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 - 14 mL Bottle Carton

    Vizuri
    PAIN
    BLOC ®
    24

    24 HOURS
    OF ARTHRITIS PAIN RELIEF*

    CAPSAICIN
    Capsaicin 0.25% Topical Analgesic

    • MAX DOSE WITHOUT
      A PRESCRIPTION
    • ODOR FREE

    †

    Arthritis
    Foundation ®
    Let's get a grip on arthritis.

    0.5 fl oz (14 mL)

    NDC:71226-001-02

    PRINCIPAL DISPLAY PANEL - 14 mL Bottle Carton
  • 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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71226-001-011 in 1 CARTON03/21/2017
    130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    2NDC:71226-001-021 in 1 CARTON08/01/2017
    214 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    3NDC:71226-001-031 in 1 CARTON08/01/2017
    345 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 finalpart34803/21/2017
    Labeler - Vizuri Health Sciences LLC (052129499)
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