Label: BURN- lidocaine spray

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

Drug Label Information

Updated January 18, 2024

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients:

    Lidocaine HCL 2%

  • PURPOSE

    Purpose:

    Topical Anesthetic

  • INDICATIONS & USAGE

    Uses:

    Temporary pain relief of minor burns

  • WARNINGS

    Warnings

    For external use only

    See a doctor immediately or serious burns

    Do not use

    • in or near the eyes
    • over large portions of the body
    • in large quantities particularly over raw surfaces or blistered areas
    • on serious burns
    • longer than 7 days unless directed by a doctor

    Stop use and ask a doctor if

    • condition worsens
    • condition lasts for more than 7 days
    • symptoms clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222

  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children 12 years of age and over:

    • clean the affected area
    • apply to the affected area not more than 3 to 4 times dailys
    • may be covered with a sterile bandage when dry

    Children under 12 years of age: ask a doctor

  • OTHER SAFETY INFORMATION

    store at 68° to 77°F (20-25°C)

  • INACTIVE INGREDIENT

    Inactive Ingredients

    aloe vera, germaben II, propylene glycol, purified water 

  • PRINCIPAL DISPLAY PANEL

    2728Burnv23f.jpg

  • INGREDIENTS AND APPEARANCE
    BURN 
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0210-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2024
    Labeler - HART Health (069560969)
    Registrant - HART Health (069560969)
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!