Label: LEADER- lidocaine hcl cream

  • 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 October 18, 2021

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  • 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

    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 over: apply to affected area not more than 3 to 4 times daily
    • children under 2 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

  • Principal display panel

    Front Label

    Leader

    NDC 70000-0098-1

    Maximum Strength

    Lidocaine

    Pain Relief

    Cream

    Lidocaine HCl 4% Topical Analgesic

    Non Greasy

    Compare to aspercreme lidocaine cream

    active ingredient

    100% Money Back Guarantee

    Net wt 2.7 oz (76.5g)

    Carton Label

  • INGREDIENTS AND APPEARANCE
    LEADER 
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0098
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    STEARETH-21 (UNII: 53J3F32P58)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0098-11 in 1 CARTON10/18/2021
    176.5 g 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 finalpart34810/18/2021
    Labeler - Cardinal Health (063997360)
    Registrant - Weeks & Leo Company Inc (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Company Inc005290028manufacture(70000-0098)
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