Label: LIDOCAINE HYDROCHLORIDE liquid

  • 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 10, 2023

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Lidocaine HCl 2.0%

  • Purpose

    Topical pain relief

  • Use

    Temporarily relieves pain associated with minor burns.

  • Warnings

    For external use only.

    Do not use

    • in eyes, if contact occurs rinse thoroughly with water
    • in large quantities, particularly over raw or blistered areas

    Stop use and ask a doctor if condition worsens, or persists for more than 7 days or clears up and returns

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

    • adults and children 2 years of age and older: spray an even layer of burn spray over affected area not more than 3-4 times daily
    • children under 2 years of age: consult a doctor
  • Inactive ingredients

    aloe vera, diazolidinyl urea, propylene glycol, purified water
    ----------

  • QUESTIONS

    Questions? 1.800.835.2263

  • PRINCIPAL DISPLAY PANEL

    Bottle Bottle LabelLabel

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE HYDROCHLORIDE 
    lidocaine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0934(NDC:61010-5100)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0934-0159.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/16/2023
    2NDC:0924-0934-02118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/16/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/16/2023
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-0934) , repack(0924-0934)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-0934) , repack(0924-0934)
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!