Label: LIDOCAINE 4% CREAM- lidocaine cream

  • NDC Code(s): 52565-122-07, 52565-122-15, 52565-122-30
  • Packager: Teligent Pharma, 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 22, 2019

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Lidocaine 4% cream is a non-greasy cream specially formulated with soothing agents, indicated as a topical anesthetic for use on normal intact skin for local analgesia and itching due to minor cuts, minor scrapes, sunburn, minor skin irritations, minor burns and insect bites.

  • INGREDIENTS

    ACTIVE: Lidocaine (4%)

  • INACTIVE:

    Butylated Hydroxytoluene, Cetostearyl Alcohol, Citric Acid, Edetate Disodium, Light Mineral Oil, Methylparaben, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate and White Petrolatum.

    The chemical designation of Lidocaine is 2-(diethylamino)-N(2,6-dimethylphenyl), acetamide. The structure of lidocaine is:


    chemical structure

  • MECHANISM OF ACTION

    Lidocaine 4% cream applied to intact skin provides dermal analgesia by the release of lidocaine from the cream into the epidermis and dermis. Lidocaine is a local anesthetic agent of the amide type. Local anesthetics reversibly block the initiation and conduction of nerve impulses by interfering with the flux of sodium ions through the neuronal membrane. The onset, depth and duration of dermal analgesia provided depend upon the site and duration of application.

  • INDICATIONS AND USAGE

    Lidocaine 4% cream is indicated for use on normal intact skin for temporary relief of pain and itching due to minor cuts, minor scrapes, minor skin irritations, minor burns and insect bites.

    Lidocaine 4% cream is not recommended for internal use, in the or near the eyes and in large quantities, particularly over raw surfaces or blistered areas.  

  • CONTRAINDICATIONS

    Lidocaine 4% cream is contraindicated in patients with sensitivity to amide type local anesthetics or to any component of the product.

  • WARNINGS

    For external use only. Avoid contact with the eyes. Do not use over large areas of the body. Do not use for more than seven days unless directed by a doctor. Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

    Inappropriate use of this product, such as on large areas of the body, application on mucous membranes, or on individuals that are allergic to the amide type anesthetics, may result in serious side effects. Consultation with a doctor before using this product is strongly recommended.

  • PRECAUTIONS

    Repeated doses of lidocaine 4% cream may increase blood levels of lidocaine. Avoid contact with the eyes. If eye contact occurs, immediately wash out the eye with water or saline.

    The patient should be aware that dermal analgesia may be accompanied by the block of all sensations in the treated skin. For this reason, the patient should avoid inadvertent trauma to the treated area by scratching, rubbing or exposure to extreme hot or cold temperatures until complete sensation has returned.

  • DRUG INTERACTIONS

    Lidocaine 4% cream should be used with caution in patients receiving Class I antiarrhythmic agents (e.g., tocainide, mexiletine) since the toxic effects are potentially additive and synergistic.

  • DIRECTIONS

  • SPL UNCLASSIFIED SECTION

    • Adults and children 2 years and older. Apply externally to the affected area up to 3 to 4 times a day.
    • Children under 2 years of age. Consult a doctor.
  • DOSAGE & ADMINISTRATION

  • HOW SUPPLIED

    NDC 52565-122-07 (5 x 5 gram tubes)
    NDC 52565-122-15 (15 gram tubes)
    NDC 52565-122-30 (30 gram tubes)

    Store at USP controlled room temperature 20° to 25°C (68° to 77°F).  

    Manufactured by:
    Teligent Pharma, Inc.
    Buena, New Jersey 08310

    PI-122-01
    Revised 09/2018

  • KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 52565-122-15

    Lidocaine Cream 4%

    Net Wt. 15 grams

    For Topical Use Only
    Do Not Use in the Eyes

    15g carton PDP
  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 4% CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52565-122
    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
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Citric Acid Acetate (UNII: DSO12WL7AU)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    Light Mineral Oil (UNII: N6K5787QVP)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Water (UNII: 059QF0KO0R)  
    Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52565-122-075 in 1 CARTON01/22/2019
    15 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:52565-122-151 in 1 CARTON01/22/2019
    215 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:52565-122-301 in 1 CARTON01/22/2019
    330 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/22/2019
    Labeler - Teligent Pharma, Inc. (011036910)
    Establishment
    NameAddressID/FEIBusiness Operations
    Teligent, Inc.011036910manufacture(52565-122)