Label: XPECT FIRST AID CREAM- benzalkonium chloride, 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 August 19, 2022

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  • Active Ingredients

    Benzalkonium chloride 0.13%

    Lidocaine HCL 0.5%

  • Purpose

    First aid antiseptic

    External analgesic

  • Uses

    first aid to help prevent infection and for the temporary relief of pain in minor cuts, scrapes and burns

  • Warnings

    For external use only

  • Do not use

    • in the eyes or apply over large areas of the body
    • longer than 1 week unless directed by a doctor
    • in large quantitites, particularly over raw surfaces or blistered areas
  • Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
  • Stop use and ask a doctor if

    condition persists or gets worse

    • symptoms persist for more than 7 days
    • condition clears up and occurs again within a few days
    • a rash or other allergic reaction develops
  • 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 of age and older

    • clean the affected area
    • may be covered with a sterile bandage
    • apply a small amount (an amount equal to the surface area of the tip of finger) 1 to 3 times daily
  • Other information

    • do not use if packet is torn, cut or opened
    • store at room temperature (do not freeze)
    • see packet for Lot Number and expiration date
  • Inactive ingredients

    aloe vera, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl monosterate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine

  • Questions

    1-877-973-2811

  • PRINCIPAL DISPLAY PANEL

    First Aid Cream

    Antixeptic and pain reliever

    Net Wt per Pkt 1.32 oz (0.9 g)

    20 pkts per box

    Front Panel

  • INGREDIENTS AND APPEARANCE
    XPECT FIRST AID CREAM 
    benzalkonium chloride, lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82940-214(NDC:42961-214)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82940-214-0120 in 1 BOX08/19/2022
    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 finalpart34808/19/2022
    Labeler - Shares Inc (081533663)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shares Inc081533663repack(82940-214)
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