Label: FIRST AID ANTISEPTIC- benzalkonium 0.13%, lidocaine hcl 2.5% spray

  • 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 July 6, 2018

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  • Active ingredients                   Purpose

    Benzalkonium 0.13%                First Aid Antiseptic

    Lidocaine HCl 2.5%                 Pain Relieving Spray

  • Uses

    First aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with minor: cuts, scrapes, burns, sunburn, skin irritations

  • Warnings

    ​ ​For external use only

    ​Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product​

    • do not use in or near the eyes
    • do not apply over large area of the body or in large quantities
    • do not apply over raw surfaces or blistered areas

    ​Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days, or 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 older: clean the affected area. Apply small amount on the area 1-3 times daily; may be covered with a sterile bandage (let dry first) • Children Under 2 years: Consult a physician.

  • Other information

    Avoid excessive heat

  • Inactive ingredients

    Diazolidinyl Urea, Disodium EDTA, Fragrance, Methylparaben, Nonoxynol 9, Propylene Glycol, Propylparaben, Sodium Phosphate Dibasic, Water

  • Questions? 888-309-9030

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTISEPTIC 
    benzalkonium 0.13%, lidocaine hcl 2.5% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-805
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE25 mg  in 1 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Methylparaben (UNII: A2I8C7HI9T)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-805-04148 mL in 1 BOTTLE; Type 0: Not a Combination Product03/07/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/07/2013
    Labeler - Meijer (006959555)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(41250-805) , label(41250-805)
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