Label: CUT CARE INSECT BITE ANTISEPTIC AND PAIN RELIEVING WIPE- benzocaine and isopropyl alcohol swab

  • 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 September 16, 2013

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  • SPL UNCLASSIFIED SECTION

  • Active Ingredients

    Benzocaine, 6% w/v

  • Purpose

    Topical Analgesic

  • Active Ingredients

    Isopropyl Alcohol, 70% w/v

  • Purpose

    Antiseptic

  • Uses

    For temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

  • Warnings

    For external use only. Flammable, keep away from fire or flame.

    Do Not Use

    • With electrocautery procedures.
    • In eyes

    Stop Use

    • If irritation and redness develop.
    • If condition persists for more than 72 hours, consult a physician.

    Keep out of Reach of Children.

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

  • Directions

    • Adults and children 2 years of age and older, apply to affected area 3-4 times daily.
    • Children under 2 years; consult a physician.
  • Other Information

    Avoid excessive heat. Store at room temperature: 15 - 30 degrees C (59 - 86 degrees F)

  • Inactive Ingredient:

    purified water

  • PRINCIPAL DISPLAY PANEL

    NDC 53439-120-10
    Cut Care
    Insect Bite Antiseptic & Pain Relieving Wipes
    First aid antiseptic
    Topical Analgesic
    Contents: 100 Pre-Moistened Wipes

    NDC 53439-120-10 Cut Care Insect Bite Antiseptic & Pain Relieving Wipes First aid antiseptic Topical Analgesic Contents: 100 Pre-Moistened Wipes

  • INGREDIENTS AND APPEARANCE
    CUT CARE INSECT BITE ANTISEPTIC AND PAIN RELIEVING WIPE 
    benzocaine and isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53439-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE.021 g
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53439-120-10100 in 1 CARTON
    1NDC:53439-120-011 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34809/15/2013
    Labeler - Zeus Medical Holdings LLC (014884052)
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