Label: MEDI-FIRST PLUS BURN WITH LIDOCAINE- benzalkonium chloride, lidocaine cream
MEDI-FIRST BURN WITH LIDOCAINE- benzalkonium chloride, lidocaine cream

  • NDC Code(s): 47682-984-73, 47682-985-73
  • Packager: Unifirst First Aid Corporation
  • 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 20, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Benzalkonium Chloride 0.13%

    Lidocaine HCl 0.5%

  • PURPOSE

    Purpose

    First aid antiseptic

    Topical analgesic

  • INDICATIONS & USAGE

    Uses

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

    Warnings

    For external use only.

  • DO NOT USE

    Do not use

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

    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

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    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
  • OTHER SAFETY INFORMATION

    Other information

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

    Inactive ingredients

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

  • QUESTIONS

    Questions or comments? 800-634-7680

  • PRINCIPAL DISPLAY PANEL

    Medi-First®

    Burn Cream with Lidocaine

    Benzalkonium Chloride 0.13% / Topical Antiseptic

    Lidocaine HCl 0,5% / Topical Analgesic

    Antiseptic and pain relieving cream for minor burns

    Item #26073

    NetWt. 0.9 g (1/32 oz) Packets / 25 per box

    Made in China

    MF Burn

  • PRINCIPAL DISPLAY PANEL

    Medi-First® Plus

    Burn Cream with Lidocaine

    Benzalkonium Chloride 0.13% / Lidocaine HCl 0.5%

    Topical Antiseptic / Topical Analgesic

    Net Wt. 0.9 g (1/32 oz) Packets / 25 per box

    Item #93973

    Made in China

    MFP Burn

  • INGREDIENTS AND APPEARANCE
    MEDI-FIRST PLUS BURN WITH LIDOCAINE 
    benzalkonium chloride, lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-985
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-985-7325 in 1 BOX04/01/2023
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2023
    MEDI-FIRST BURN WITH LIDOCAINE 
    benzalkonium chloride, lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-984
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-984-7325 in 1 BOX04/01/2023
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2023
    Labeler - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medique Products086911794pack(47682-984, 47682-985)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761pack(47682-984, 47682-985)