Label: LEADER LIDOCAINE- lidocaine hcl 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 5, 2022

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

View All Sections
  • Active Ingredient

    Lidocaine HCl 4%

  • Purpose

    Topical analgesic

  • Uses

    temporarily relieves pain and itching due to:

    • minor burns
    • sunburn
    • minor cuts
    • scrapes
    • insect bites
    • minor skin irritations
  • Warnings

    For external use only

    Do not use in large quantities, particularly over raw surfaces or blistered areas

    When using this product do not get into eyes

    Stop use and ask a doctor if

    • condition gets worse
    • symptoms last for more than 7 days
    • symptoms clear up and occur again within a few days

    Flammable •Keep away from fire or flame

    If pregnant or breast-feeding, ask a health professional before use

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

  • Directions

    • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
    • children under 12 years: ask a doctor
  • Other information

    store between 20 °C and 25 °C (68 °F and 77 °F)

  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, aminomethyl propanol,
    C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl monostearate, methylparaben, purified water, SD alcohol 40, steareth-21

  • Questions or comments?

    call 515-276-1586

  • Principal display panel

    lidocaine front label

    Leader

    NDC 70000-0099-1

    Maximum Strength

    Lidocaine

    Pain Relief

    Liquid

    Lidocaine HCl, 4% Topical Analgesic

    No Mess

    Applicator

    Compare to

    Aspercreme

    Lidocaine liquid

    active ingredient

    100% Money Back Guarantee

    2.5 Fl oz (73 mL)

  • INGREDIENTS AND APPEARANCE
    LEADER LIDOCAINE 
    lidocaine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0099
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    STEARETH-21 (UNII: 53J3F32P58)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0099-11 in 1 CARTON10/20/2021
    173 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/20/2021
    Labeler - CARDINAL HEALTH (063997360)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc.005290028manufacture(70000-0099)
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!