Label: QC LIDOCAINE MAXIMUM STRENGTH- lidocaine hcl cream

  • NDC Code(s): 63868-956-01
  • Packager: Chain Drug Marketing Association
  • 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 December 7, 2020

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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

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

    When using this product

    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

  • 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

  • Prinicpal display panel

    Quality Choice

    Maximum Strength Lidocaine Cream Lidocaine HCL 4 %- Topical Analgesic

    Steroid free, Works on Contact

    Carton

  • INGREDIENTS AND APPEARANCE
    QC LIDOCAINE  MAXIMUM STRENGTH
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-956
    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
    STEARETH-21 (UNII: 53J3F32P58)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-956-011 in 1 CARTON12/07/2020
    149.6 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 finalpart34812/07/2020
    Labeler - Chain Drug Marketing Association (011920774)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc.005290028manufacture(63868-956)
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