Label: NULIDO- lidocaine hydrocloride 4% gel

  • 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 October 18, 2017

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  • Active Ingedients

    Each milliliter contains
     Active Ingredient Purpose
     Lidocaine Hydrochloride 4.0% Topical Anesthetic
     Menthol 1.0% Topical Anesthetic
  • INACTIVE INGREDIENT

    Carbomer copolymer type b, Isopropyl Alcohol, water, trolamine

  • Warnings

    For external use only.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away. Package not child resistant.

  • When using this product

    ■ avoid contact with eyes, genitals, and other mucous membranes. If eye contact occurs, rinse thoroughly with water.
    ■ do not use on open wounds, cuts, damaged or infected skin
    ■ do not use With a bandage or a heating pad

  • Ask your doctor before use if

    ■ you are allergic to any ingredients
    ■ you are pregnant or breast-feeding

  • Uses

    Temporarily relieves minor aches and muscle pains associated with:


    ■ arthritis

    ■ simple back pain

    ■ strains

    ■ muscle soreness

  • Purpose

    Temporarily relieves minor aches and muscle pains associated with:

    ■ arthritis
    ■ simple back pain
    ■ strains
    ■ muscle soreness

  • Dosage & Administration

    Apply to the affected area.
     Adults and children 12 years and older

     Apply to the affected area.
    Product may be used as necessary, but should not
    be used more than four times per day.


    Wash hands immediately afterwards.
    Children under 2Ask a doctor

  • Other Information

    ■ avoid storing product in direct sunlight
    ■ protect product from excessive moisture
    ■ store at 67-77°F (19-25°C)

  • Stop Use and Ask Doctor

    ■ if condition worsens or symptoms persist for more than 7 days
    ■ if excessive skin irritation occurs

  • Label Image

    Manufactured by:
    All Pharma, LLC
    Hialeah, FL 33016
    www.allpharmallc.com
    Made in the U.S.A.

    NuLido Label

  • INGREDIENTS AND APPEARANCE
    NULIDO 
    lidocaine hydrocloride 4% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53149-2100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53149-2100-4120 mL in 1 TUBE; Type 0: Not a Combination Product10/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2017
    Labeler - All Pharma LLC (117605075)
    Establishment
    NameAddressID/FEIBusiness Operations
    All Pharma LLC117605075MANUFACTURE(53149-2100)
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