Label: LIDOCAINE 4% TOPICAL ANESTHETIC CREAM- lidocaine 4% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 10, 2024

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

  • Drug Facts Active Ingredients

    Lidocaine 4% w/w

  • Purpose

    Topical Anesthetic

  • Uses

    Temporarily relieves pain and itching due to:

    • Minor cuts
    • Minor scrapes
    • Sunburn
    • Minor burns
    • Minor skin irritations
    • Insect bites
  • Warnings

    For external use only.

  • When using this product

    • Do not use in or near the eyes.
    • Do not use in large quantities, particularly over raw surfaces or blistered areas.
  • Stop use and ask a doctor if

    • Allergic reaction occurs.
    • Condition worsens or does not improve within 7 days.
    • Symptoms clear up and return within a few days.
    • Redness, irritation, swelling, pain or other symptoms begin or increase.
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

    You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7900 or FDA at 1-800-FDA-1088.

  • Directions

    • Adults and children 2 years and older: apply externally to the affected area up to 3-4 times daily.
    • Children under 2 years of age: consult a physician.
  • SPL UNCLASSIFIED SECTION

    Lidocaine
    4% Cream

  • Inactive Ingredients

    Cetyl alcohol, Citric acid, Glycerin, Glyceryl stearate SE, Mineral oil, PEG-100 stearate, Phenoxyethanol, Purified water, Stearyl alcohol, White
    petrolatum, Xanthan gum.

  • SPL UNCLASSIFIED SECTION

    See crimp of tube or carton for lot and exp. date.

    RETAIN CARTON FOR COMPLETE DRUG FACTS.

  • Other information

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

    Manufactured In USA For :

    ONCOR PHARMACEUTICALS
    8815 Center Park Dr Suite 430
    Columbia
    Maryland 21045
    Rev. 05/24

  • Package Label

    ONCOR PHARMACEUTICALS

    NDC 83720- 523-01

    Lidocaine 4% Cream

    Topical Anesthetic Cream

    For External Use Only
    Not For Ophthalmic Use

    This product contains child-resistant
    packaging. To open, push down on the cap of the tube while turning and lift off.

    NET WT. 1.05 OZ. (30 gm)

    Carton

    ONCOR PHARMACEUTICALS

    NDC 83720- 523-01

    Lidocaine 4% Cream

    Topical Anesthetic Cream

    For External Use Only
    Not For Ophthalmic Use

    This product contains child-resistant
    packaging. To open, push down on the cap of the tube while turning and lift off.

    NET WT. 1.05 OZ. (30 gm)

    Tube

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 4% TOPICAL ANESTHETIC CREAM 
    lidocaine 4% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83720-523
    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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83720-523-011 in 1 CARTON05/10/2024
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/10/2024
    Labeler - Oncor Pharmaceuticals (119032580)
    Registrant - Oncor Pharmaceuticals (119032580)