PAINBLOC24 (CAPSAICIN 0.25%) SOLUTION [VIZURI HEALTH SCIENCES LLC]

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PAINBLOC24 (CAPSAICIN 0.25%) SOLUTION [VIZURI HEALTH SCIENCES LLC]
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NDC 71226-001-01, 71226-001-02, 71226-001-03
Set ID d856dbc8-20e7-4f47-ac7b-81bb94362edc
Category HUMAN OTC DRUG LABEL
Packager Vizuri Health Sciences LLC
Generic Name
Product Class
Product Number
Application Number PART348
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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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac, Inc071609663MANUFACTURE(71226-001)
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