Label: LIDOCAINE cream

  • NDC Code(s): 75834-141-30
  • Packager: Nivagen Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated October 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Lidocaine 5% w/w

  • Purpose

    Topical anesthetic

  • Uses

    Temporarily relieves the pain and itching due to anorectal disorders.

  • Warnings

    For external use only.

    When using this product

    • avoid contact with eyes
    • do not use in large quantities, particularly over large surfaces or blistered areas
    • do not exceed recommended dosage unless directed by a doctor
    • do not put this product into the rectum by using fingers or any mechanical device or applicator.

    Stop use and ask a doctor if

    • rectal bleeding occurs
    • condition worsens or does not improve within 7 days
    • allergic reaction occurs to ingredients in this product
    • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
    • symptoms clear up and return within a few days

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

  • Directions

    • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
    • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
    • Children under 12 years of age: consult a doctor.
  • Other Information

    Store at 25°C (77°C); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

  • Inactive Ingredients

    benzyl alcohol,carbomer hompolymer type C, C10-18 triglycerides, cholesterol, lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopherol, trolamine, water

  • Questions?

    1-877-977-0687

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    NDC 75834-141-30

    Lidocaine 5%
    Topical Anesthetic Cream-Anorectal

    NIVAGEN
    PHARMACEUTICALS

    net wt. 30 g (1 oz)

    PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75834-141
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75834-141-3030 g in 1 TUBE; Type 0: Not a Combination Product12/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/15/2016
    Labeler - Nivagen Pharmaceuticals, Inc. (052032418)
    Registrant - Westwood Laboratories, LLC (832280635)
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