VENIA PATCH PREMIUM PAIN PATCH (MENTHOL, LIDOCAINE) PATCH [ALIVIO MEDICAL PRODUCTS, LLC]

VENIA PATCH PREMIUM PAIN PATCH (MENTHOL, LIDOCAINE) PATCH [ALIVIO MEDICAL PRODUCTS, LLC]
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NDC 69512-700-05
Set ID bfe40c92-cdb7-4b61-ab21-a36cf694fd29
Category HUMAN OTC DRUG LABEL
Packager Alivio Medical Products, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active Ingredients

    Menthol 4 %

    Lidocaine 4 %

  • PURPOSE

    Purpose

    Topical anesthetic

    Topical anesthetic

  • INDICATIONS & USAGE

    Uses:

    For the temporary relief of minor aches and muscle pains associated with arthritis, simple

    backache, strains, muscle soreness and stiffness

  • WARNINGS

    Warnings:

    -Only for external use. Use only as directed or by a health professional.

    -Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth,

    genitals, or any other mucous membranes.

    -Do not cover with bandage.

    -Keep out of reach of children.Consult physician for children under 12.

    -Consult your physician: if pregnant or pain persists or worsens.

  • DOSAGE & ADMINISTRATION

    Directions:

    -Adults and children 12 years and over. Apply patch to affected area 1 to 2 times daily or

    as directed.

    -Instructions for use:

    -Clear and dry the affected area

    -Open pouch and remove one patch

    -Remove any protective film and apply directly to affected area of pain

    -Wash hands with soap and water after applying patch

    -Reseal pouch containing unused patches after each use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Consult physician for children under 12

  • INACTIVE INGREDIENT

    Other ingredients:

    Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium, 2 Ethylhexyl Acrylate, Glycerin, Isopropyl

    Myristate, Methyl Acrylate, Nonoxynol 30, Polyacrylate, Polyacrylic Acid, Polysorbate 80, Sorbitan

    Sesquioleate, Starch, Talc, Tartaric Acid, Titanium Dioxide, Water

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    VENIA PATCH  PREMIUM PAIN PATCH
    menthol, lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69512-700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM4 mg  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69512-700-0510 in 1 BOX
    11 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2015
    Labeler - Alivio Medical Products, LLC (079670828)

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