Label: INSECT BITE RELIEF- benzocaine solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 12, 2013

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  • Drug Fact

    Active ingredient

    Benzocaine 15%

  • Purpose

    Benzocaine for  Pain Relief

  • Uses

    temporary relief of pain and itching associated with insect bites, scrapes, minor cuts, minor burns, sunburn, or skin irritation

  • Warnings

    For external use only. do not bandage.

    Do not use. in the eyes or apply over large areas of the body, particularly over raw surfaces or blistered area - if product gets into the eyes. flush throughly with water and obtain medical attention. longer than one week unless directed by doctor.

    Stop use and ask a doctor if. condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ♦   Do not use if label seal is broken prior to purchase. Keep swabs in original container when not in use.

    ♦   Hold the swab vertically, with the color band tip upwards. hold in the center of the stem with one hand and at the color band with the other.

    ♦  Bend the tip at the color band to one side until it snaps.

    ♦  Apply the product to the affected area.

    ♦  Discard swab after use.

  • Administration

    For adult and children 2 and older. Apply directly onto affected area no more than 3 to 4 times daily.

    Children under 2 years of age. Do not use, consult a doctor.

  • Other information

    Avoid storing at excessive heat.

  • Inactive ingredients

    Aloe Vera Gel. Ethoxydiglycol (diethylene glycol monoethyl ether), Glycerin, Menthol, PEG-8 (Polyethylene glycol 400), Propylene Glycol, Triclosan

  • Package Display Panel

    Image of insect bite carton label

    Image of insect bite carton label

  • INGREDIENTS AND APPEARANCE
    INSECT BITE RELIEF 
    benzocaine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65734-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    Glycerin (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Triclosan (UNII: 4NM5039Y5X)  
    Menthol (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65734-300-3636 in 1 PACKAGE
    1NDC:65734-300-000.15 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/01/2003
    Labeler - Swabplus Inc. (876441549)
    Registrant - Swabplus Inc. (876441549)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swabplus Inc.876441549manufacture(65734-300) , relabel(65734-300) , repack(65734-300)
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