Label: BITE AND STING RELIEF- benzocaine - 5.00% cream

  • 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 9, 2018

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  • Active ingredients                   Purpose

    Benzocaine                                5.00%

  • PURPOSE

  • Uses

    For temporarily relief of pain and itching associated with insect bites

  • WarningFor external use only

    When using this product avoid contact with eyes and mucous membranes

    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
    If product is swallowed, get medical help or contact a Poison Control Center right away
    In case of accidental ingestion, seek professional or contact a Poison Control Center immediately.

  • Direction

    Adults and children 2 years of age and older: • apply to the affected area nor mre than 3 to 4 times daily. Children under 2 years of age: consult a doctor

  • Inactive ingredients

    Water
    PEG-2 Stearate
    PEG-2 Stearate SE
    SD Alcohol 40
    Polyethylene
    Hydrocortisone
    Methylparaben
    Aloe Barbadensis Leaf Extract
    Propylparaben
    Chamomilla Recutita (Matricaria) Flower Extract
    Propylene Glycol
    Diazolidinyl Urea
    Disodium EDTA
    Olea Europaea (Olive) Fruit Oil
    Camphor
    Menthol
    Mentha Piperita (Peppermint) Oil
    Eugenia Caryophyllus (Clove) Flower Oil
    Papain

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BITE AND STING RELIEF 
    benzocaine - 5.00% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-718
    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
    Water (UNII: 059QF0KO0R)  
    PEG-2 Stearate (UNII: 94YQ11Y95F)  
    ALCOHOL (UNII: 3K9958V90M)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Hydrocortisone (UNII: WI4X0X7BPJ)  
    Methylparaben (UNII: A2I8C7HI9T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    Menthol (UNII: L7T10EIP3A)  
    Peppermint (UNII: V95R5KMY2B)  
    CLOVE OIL (UNII: 578389D6D0)  
    Papain (UNII: A236A06Y32)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-718-021 in 1 CARTON08/06/2012
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/06/2012
    Labeler - Top care (006935977)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(36800-718) , label(36800-718)
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