POINT RELIEF LIDOSPOT (LIDOCAINE HCL, MENTHOL) PATCH [FABRICATION ENTERPRISES]

POINT RELIEF LIDOSPOT (LIDOCAINE HCL, MENTHOL) PATCH [FABRICATION ENTERPRISES]
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NDC 51452-727-01
Set ID 7107e22e-9332-4509-b368-32296acb5648
Category HUMAN OTC DRUG LABEL
Packager Fabrication Enterprises
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • Drug Facts

  • ACTIVE INGREDIENT

    Lidocaine HCl 4%

    Menthol 1%

  • PURPOSE

    Topical Anesthetic

    External Anesthetic

  • USES

    For temporary relief of pain and itching associated with minor burns, cuts, scrapes and minor skin irritations.

  • WARNINGS

    • For External use only. Use only as directed.
    • Avoid contact with eyes and mucous membranes.
    • If symptoms persist for more than 7 days, discontinue use and consult a physician
    • If swallowed, consult a physician.

    • Keep out of reach of children. Consult a physician prior to using on children under 12.

    • Do not apply to open wounds or damaged skin.
    • Do not use oils, lotions or powders on treatment area prior to application.
    • Do not use with any bandage, wrap, stocking or similar device or garment.

    • If pregnant or breast feeding, contact a physician prior to use.
  • DIRECTIONS

    • Apply to treatment area.
    • How to apply:
    • Clean and dry treatment area.
    • If customized size is needed, cut patch to the desired size/shape with scissors.
    • Remove protective backing from patch to expose active ingredient and adhesive.
    • Apply patch to treatment area.
    • Use only one patch at a time. Use a maximum of four patches per day.
    • Leave patch on treatment area for up to 12 hours.
    • Do not use patches for longer than 5 consecutive days.
  • OTHER INGREDIENTS

    Water, Glycerol, Sodium polyacrylate, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Camellia Sinensis (Green Tea) Extract, Aluminiumglycinate, Titaniumdioxide, Kaolin, Tween 80, Propylene glycol, Tartaric acid, PVP, Polyacrylic acid, Methylparaben, Propylparaben.

  • STORAGE AND HANDLING

    Store at room temperature

    Avoid direct sunlight

  • Representative Labeling

    LidoSpot

  • INGREDIENTS AND APPEARANCE
    POINT RELIEF LIDOSPOT 
    lidocaine hcl, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51452-727
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TARTARIC ACID (UNII: W4888I119H)  
    PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    KAOLIN (UNII: 24H4NWX5CO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51452-727-015 in 1 POUCH03/02/2016
    18 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/02/2016
    Labeler - Fabrication Enterprises (070577218)

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