Label: LIDOCAINE- lidocaine 4% cream

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

Drug Label Information

Updated March 6, 2024

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

View All Sections
  • Active Ingredient:

    Lidocaine 4% w/w

  • Purpose

    Topical anesthetic

  • Uses

    temporarily relieves pain and itching due to:

    • minor cuts
    • minor scrapes
    • sunburn
    • minor skin irritations
    • minor burns
    • 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 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

  • 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 doctor.
  • Other Information

    Store at USP controlled room temperature 20-25 degC (68-77 deg.F).

  • Inactive ingredients

    Cetyl alcohol, citric acid, glycerin, glyceryl stearate SE, mineral oil, PEG-100 stearate, phenoxyethanol, purified water, stearyl alcohol, white petrolatum, xanthan gum

  • PRINCIPAL DISPLAY PANEL

    30

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 
    lidocaine 4% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42291-399
    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
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42291-399-301 in 1 CARTON07/10/2018
    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 DrugM01707/10/2018
    Labeler - AvKARE (796560394)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!