Label: MEDI-FIRST- benzalkonium chloride, lidocaine cream

  • NDC Code(s): 71927-019-01, 71927-019-03
  • Packager: Orazen Inc
  • 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 February 20, 2023

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  • Active ingredients

    Benzalkonium Chloride 0.13%

    Lidocaine HCI 0.5%

  • Purpose

    First aid antiseptic

    Topical analgesic

  • Uses

    • for the temporary relief of pain associated with minor burns
    • helps protect against harmful bacteria
  • Warnings

    For external use only.

  • Do not use

    • in the eyes
    • in large quantities
    • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
    • for more than one week unless directed by a doctor

  • Stop use and ask a doctor if

    • the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • Keep out of reach of children.

    If ingested, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 2 years and over: clean the affected area, apply a small amount not more than 3 to 4 times daily
    • Children under 2 years: do not use, consult a doctor

    (continued on next panel)

  • Other information

    • store at room temperature (do not freeze)
    • tamper evident sealed packets
    • do not use any opened or torn packets
  • Inactive ingredients

    aloe barbadensis leaf juice, cetearyl alcohol,disodium EDTA, ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, maltodextrin, propylene glycol, purified water, PEG-100 stearate,phenoxyethanol, stearic acid, triethanolamine

  • Questions or comments?

    800-634-7680

  • Package Label - Principal Display Panel

    image of pouch label

    image of box label

  • INGREDIENTS AND APPEARANCE
    MEDI-FIRST 
    benzalkonium chloride, lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71927-019-0325 in 1 BOX02/20/2023
    1NDC:71927-019-010.9 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/20/2023
    Labeler - Orazen Inc (080916640)
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