NULIDO LIDOCAINE PATCH PLUS MENTHOL (LIDOCAINE, MENTHOL) PATCH [ALL PHARMA LLC]

NULIDO LIDOCAINE PATCH PLUS MENTHOL (LIDOCAINE, MENTHOL) PATCH [ALL PHARMA LLC]
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NDC 53149-2200-1
Set ID 3ae5277f-8974-41e2-ad68-801977d0e269
Category HUMAN OTC DRUG LABEL
Packager All Pharma LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • Drug Facts

  • ACTIVE INGREDIENT

    Lidocaine 4% Topical Anesthetic

    Menthol 1% Topical Anesthetic

  • PURPOSE

    Topical Anesthetic

  • USES

    Temporary relief of minor pain

  • WARNINGS

    • For External use only. Use only as directed.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    ■ More than one patch on your body at a time

    ■ On cut, irritated or swollen skin

    ■ On puncture wounds

    ■ For more than one week without consulting a doctor

    ■ If you are allergic to any active or inactive ingredients

    ■ If pouch is damaged or opened.

    If pregnant or breast feeding

    • Contact a physician prior to use.

    WHEN USING:

    ■ Use only as directed

    ■ Read and follow all directions and warnings on this carton

    ■ Do not allow contact with the eyes

    ■ Do not use at the same time as other topical analgesics

    ■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use

    ■ Do not microwave

    ■ Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain
    the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

    Stop use and consult a doctor if

    ■ Condition worsens

    ■ Redness is present

    ■ Irritation develops

    ■ Symptoms persist for more than 7 days or clear up and occur again within a few days

    ■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

  • DIRECTIONS Adults and children 12 years of age and over:

    Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side
    of patch to affected area. Use one patch for up to 12 hours. Discard after single use.
    Children under 12 years of age: consult a physician.

  • INACTIVE INGREDIENTS

    aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol,
    propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

  • STORAGE AND HANDLING

    Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

  • DIST. BY All Pharma LLCHialeah, FL 33016

    nulidopatch

  • INGREDIENTS AND APPEARANCE
    NULIDO LIDOCAINE PATCH PLUS MENTHOL 
    lidocaine, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53149-2200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53149-2200-115 in 1 POUCH07/01/2018
    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 finalpart34807/01/2018
    Labeler - All Pharma LLC (078572520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(53149-2200)

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