Label: BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE liquid

  • 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 27, 2022

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  • PURPOSE

    first aid to help prevent skin infection, and for temporary relief of pain

  • Drug Facts

    Active ingredient Purpose

    Benzalkonium Cl 0.13% w/w...............................Fist aid Antiseptic

    lidocaine HCl 2.5% w/w......................................Pain reliever

  • Uses

    first aid to help prevent bacterial contamination or skin infections, 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 areas 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 a small amount on the area 1 to 3 times daily.

    ■ may be covered with a sterile bandage

    ■ if bandaged, let dry first




  • Other information

    Protect from excessive heat.

  • Inactive ingredients

    Camphor, Deionized water, Propylene glycol

  • Questions?

    1-800-635-3696

  • Principal Display Panel - Rite Aid Pain Relieving Antiseptic Spray 5 FL OZ Label

    label

  • INGREDIENTS AND APPEARANCE
    BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE 
    benzalkonium chloride and lidocaine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-2001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 1 mL
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-2001-1148 mL in 1 BOTTLE; Type 0: Not a Combination Product07/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/25/2022
    Labeler - Rite Aid (014578892)
    Registrant - Wisconsin Pharmacal Company, LLC (800873986)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wisconsin Pharmacal Company, LLC800873986manufacture(11822-2001) , pack(11822-2001) , label(11822-2001)
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