Label: BITE AND STING RELIEF WELL AT WALGREENS- benzocaine - 5.00% spray

  • Category: HUMAN OTC DRUG LABEL

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 January 30, 2018

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  • Active ingredient                   Purpose

    Benzocaine - 5.00%                Pain Relief

  • PURPOSE

  • Uses

    For temporarily relief of pain and itching associated with insect bites

  • WarningsFor external use only

    Flammable: ​ do not use while smoking or near heat or flame

  • When using this product

    • avoid contact with eyes
    • use only as directed
    • do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120F
  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children
    In case of accidental ingestion, seek professional or contact a Poison Control Center immediately.

  • Direction

    • shake well
    • 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 ingredients

    Aloe Barbadensis Leaf Juice, Ascorbic Acid, Camphor, Chamomilla Recutita (Matricaria) Flower Extract, Cholecalciferol, Diisopropyl Adipate,
    Eugenia Caryophyllus (Clove) Flower Oil, Fragrance, Mentha Piperita (Peppermint) Oil, Octyldodecanol, Olea Europaea (Olive) Fruit Oil,
    PEG-8 Dimethicone, Propylene Glycol, Pyridoxine HCl, Retinyl Palmitate, SD Alcohol 40, Silica, Sodium Propoxyhydroxypropyl Thiosulfate Silica,
    Tocopheryl Acetate, Zea Mays (Corn) Oil

  • Questions and comments?

    1-866-483-2846

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BITE AND STING RELIEF  WELL AT WALGREENS
    benzocaine - 5.00% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3190
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Cholecalciferol (UNII: 1C6V77QF41)  
    Diisopropyl Adipate (UNII: P7E6YFV72X)  
    CLOVE OIL (UNII: 578389D6D0)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Octyldodecanol (UNII: 461N1O614Y)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PEG-8 Dimethicone (UNII: GIA7T764OD)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Alcohol (UNII: 3K9958V90M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Sodium Propoxyhydroxypropyl Thiosulfate Silica (UNII: 208G222332)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CORN OIL (UNII: 8470G57WFM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-3190-0385 g in 1 CAN; Type 0: Not a Combination Product03/15/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/15/2013
    Labeler - Walgreens (008965063)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(0363-3190) , label(0363-3190)
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