Label: HEMPVANA COLD AS ICE PAIN RELIEF GEL-PATCH- menthol patch

  • 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 November 15, 2019

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  • Drug Facts

  • Active Ingredient:

    Menthol 5%

  • Purpose

    Menthol 5%................Topical Anesthetic

  • Uses

    temporarily relief of pain

  • Warnings

    For external use only

    Do not use

    • more than one patch at a time
    • on wounds, cuts, damaged, broken and/or irritated skin
    • over raw surfaces or blistered areas
    • at the same time as other topical analgesics
    • if allergic to menthol or any inactive ingredients
    • if package is damaged or opened

    When using this product

    • Use only as directed. Read and follow all directions and warnings on this label
    • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • Avoid contact with eyes or mucous membranes

    Stop use and ask a doctor if

    • Condition worsens
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
    • Redness is present or irritation develops

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

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

  • Directions

    Adults and children over 12 years of age

    • Clean and dry affected area
    • follow application insructions above to apply patch to skin
    • Apply one patch to affected area no more than 3-4 times daily
    • Remove patch from affected area after maximum of 8 hour application
    • Children uner 12 years of age: consult a doctor
  • STORAGE AND HANDLING

    • Avoid storing patches in direct sunlight. Protect patches from excessive moisture
  • Inactive Ingredients

    Dihydroxyaluminum Aminoacetate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Propylparaben, Sodium polyacrylate,Tartaric Acid, Titanium Dioxide, Water

  • Questions?

    Call (855) 877-4503 (M-F, 9am-5pm EST)

  • PRINCIPAL DISPLAY PANEL

    Hempvana Menthol Patch

  • INGREDIENTS AND APPEARANCE
    HEMPVANA COLD AS ICE  PAIN RELIEF GEL-PATCH
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73287-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73287-005-017 in 1 CARTON11/15/2019
    18 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 finalpart34811/15/2019
    Labeler - Telebrands Corp (177266558)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(73287-005)
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