Label: NIRAVI 24 HOURS LIDOCAINE 4 % PATCH- lidocaine patch

  • NDC Code(s): 73638-901-01
  • Packager: Sparsha Pharma USA, Inc.
  • 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 January 7, 2023

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  • Active Ingredient

    Lidocaine 4%

  • Purpose

    Topical anesthetic

  • Use

    For the temporary relief of minor pain.

  • Warnings

    For External Use Only

  • Do not use

    • If you are allergic to any active or inactive ingredients of this product
    • On wounds or damaged, irritated or sensitive skin
    • With any other topical anesthetic
    • For more than one week without consulting a doctor
    • With a heating pad
    • If pouch is damaged or opened.

  • When using this product

    • Do not allow contact with the eyes
    • Use only as directed
    • Read and follow all directions and warnings on this package
    • Do not bandage tightly or apply local heat to the area of use
    • Do not reuse patch
    • Keep this product away from pets and children. Used patches still contains the drug product that can produce serious adverse effect if child or pet chews or ingest this patch.

  • Stop use and ask a doctor if

    • Condition worsens
    • Symptoms persist for more than seven days or clear up and occur again within a few days
    • Localized skin reactions occur such as rash, pain, itching, redness, irritation, swelling or blistering where the product was applied.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and pets. If chewed or swallowed, get medical help or contact a Poison Control Center right away (800-222-1222).

  • Directions

    Adults and children 12 years of age and over: Clean and dry affected area. Apply immediately upon removal from pouch. Peel off the first liner and apply exposed patch to affected area. Peel off second liner while applying the rest of patch. Remove patch after 24 hours. Do not expose area to heat.

    Children under 12 years of age: Consult a doctor.

  • Inactive Ingredients

    Alicyclic hydrocarbon resin, mineral oil, polyester film, silicon-coated polyester film and styrene isoprene styrene block copolymer.

  • Other information

    .Store in a clean, dry place away from direct sunlight. Store in original unopened pouch. protected from moisture.

  • Questions ?

    Customer Care Helpline 844-348-5423 Monday- Friday 8:30 a.m – 4:30 p.m PST

  • PACKAGE LABEL

    Carton Label NDC 73638-901-01

    image description

    Pouch Label

    image description

  • INGREDIENTS AND APPEARANCE
    NIRAVI 24 HOURS LIDOCAINE 4 % PATCH 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73638-901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB)  
    STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (STYRENE/ISOPRENE 15/85) (UNII: 1SSZ6HXE7P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73638-901-016 in 1 CARTON06/30/2021
    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 finalpart34806/30/2021
    Labeler - Sparsha Pharma USA, Inc. (079365856)
    Registrant - Sparsha Pharma USA, Inc. (079365856)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sparsha Pharma USA, Inc.079365856manufacture(73638-901)
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