Label: ANTISEPTIC PAIN RELIEVING- 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 April 27, 2018

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  • ACTIVE INGREDIENT

    Active ingredient                                     Purpose
    Benzocaine USP  20%.......................................External analgesic

    Benzalkonium Chloride   0.1%...........................First Aid Antiseptic

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves pain and itching due to: • sunburn • minor burns • minor cuts • scrapes • insect bites • minor skin irritations• first aid to help prevent infection in minor cuts, scrapes, bites and burns

  • WARNINGS

    Warnings
    For external use only.

    Flammable: Do not use while smoking or near heat or flame Do not use in large quantities, particularly over raw surfaces or blistered areas
    When using this product
    • keep out of eyes
    • do not apply over large areas of the body or in large quantites. in case of deep or puncture wounds, animal bites, or serious burns, concult a doctor
    Stop use and ask doctor if
    • condition gets worse • symptoms last more than 7 days
    • symptoms clear up and occur again in a few days

    •do not use longer than 1 week unless directed by doctor

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Alcohol Denat.
    Diisopropyl Adipate
    Propylene Glycol
    Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC PAIN RELIEVING 
    benzalkonium chloride 0.10% benzocaine 20.00% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7779
    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:0363-7779-0385 g in 1 CAN; Type 0: Not a Combination Product07/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/31/2017
    Labeler - Walgreens (008965063)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(0363-7779) , label(0363-7779)
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