Label: FIRST AID MEDICATED RITE AID- benzalkonium chloride 0.10% benzocaine 20.00% 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 June 6, 2018

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

  • ACTIVE INGREDIENT

    Active ingredients                                                                    Purpose
    Benzalkonium Chloride 0.10%...................................................First aid antiseptic
    Benzocaine USP 20.00%...........................................................External Analgesic

  • PURPOSE

  • INDICATIONS & USAGE

    Uses • for temporary relief of pain and itching associated with minor cuts,
    scrapes, minor burns and

  • WARNINGS

    Warnings
    For external use only.
    Flammable: Do not use while smoking or near heat or flame
    Do not use • in the eyes • over large areas of the body • longer than 1 week unless
    directed by a doctor.
    When using this product • keep out of eyes. Rinse with water to remove. • use only
    as directed. • Do not puncture or incinerate. Contents under pressure. Do not store at
    temperatures above 120ºF.
    Ask a doctor before use if you have • deep or puncture wounds • animal bites
    • serious burns
    Stop use and ask doctor if • condition worsens • symptoms persist for more than 7
    days or clear up and occur again with in a few days • needed for longer than 1 week

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison
    Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions • adults and children 2 years of age and older: clean the affected
    area. Spray small amount of this product on the area, not more than 1 to 3 times daily.
    • may be covered with a sterile bandage, let dry first. • children under 2 years of age:
    consult a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients

    Alcohol Denat., Diisopropyl
    Adipate, Propylene Glycol, Tocopheryl Acetate.

  • Questions? 1-800-RITEAID (1-800-748-3243)

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FIRST AID MEDICATED  RITE AID
    benzalkonium chloride 0.10% benzocaine 20.00% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-7801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.1 g  in 100 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Diisopropyl Adipate (UNII: P7E6YFV72X)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-7801-385 g in 1 CAN; Type 0: Not a Combination Product08/03/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/03/2017
    Labeler - Rite Aid (014578892)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(11822-7801) , label(11822-7801)