Label: BITE RELIEF SCHERER LABS- 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 March 29, 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

    Acrylates/Dimethicone Copolymer
    BHT
    Bisabolol
    C12-15 Alkyl Benzoate
    Capryloyl Glycine
    Caprylyl Glycol
    Cedrus Atlantica Bark Extract
    Cetyl Dimethicone
    Chlorphenesin
    Cinnamomum Zeylanicum Bark Extract
    Cyclopentasiloxane
    Disodium EDTA
    Ethylhexyl Stearate
    Ethylhexylglycerin
    Glycerin
    Hydrated Silica
    Mannan
    Neopentyl Glycol Diheptanoate
    Phenoxyethanol
    Polyester-7
    Polyester-8
    Portulaca Oleracea Extract
    Propylene Glycol
    Sarcosine
    Sodium Polyacrylate
    Steareth-100
    Steareth-2
    Styrene/Acrylates Copolymer
    Trideceth-6
    Water
    Xanthan Gum

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    BITE RELIEF  SCHERER LABS
    benzocaine - 5.00% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64048-7336
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) Benzocaine5 g  in 100 mL
    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:64048-7336-21 in 1 CARTON02/10/2012
    152 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/10/2012
    Labeler - Product Quest Mfg. (927768135)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(64048-7336) , label(64048-7336)
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