Label: FIRST DEGREE BURN- benzocaine, triclosan 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 July 25, 2013

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  • Active ingredients

    Benzocaine 20.0%

    Triclosan 0.13%

  • Purpose

    Pain relieving spray

    First aid antiseptic

  • Uses

    • for temporary relief of pain and itching from minor burns, cuts and scrapes
    • first aid to help prevent infection in minor burns, cuts and scrapes
  • Warnings

    For external use only.

    Flammable: Do not use while smoking or near heat or flame.

  • Do not use

    • in the eyes
    • over large areas of the body
  • When using this product

    • keep out of eyes
    • use only as directed
    • do not puncture or incinerate. Contents under pressure. Do not store at
      temperature above 120°F.
  • Ask a Physician before use if you have

    • serious burns
    • deep or puncture wounds
    • existing infection
    • animal bites
  • Stop use and ask a physician if

    • conditions persist or worsen
    • rash or other allergic reaction develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • needed for longer than 1 week
  • Keep out of reach of children.

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

  • Directions

    • shake well
    • adults and children 2 years of age and older: clean affected area, spray small amount of this product on the area, not more than 1 to 3 times daily
    • if bandaged, let dry first
    • children under 2 years of age: consult a physician
    • to apply to face, spray into palm of hand and gently apply
  • Inactive ingredients

    SD Alcohol 40, Propylene Glycol, Disopropyl Adipate, Tocopheryl Acetate (Vitamin E Acetate)

  • Questions or comments?

    1-888-565-BURNCARE (565-2876)
    Monday through Friday, 9am-5pm

  • Principal Display Panel

    Maximum Pain Relief

    First°Degree® Burn Spray

    • instant pain relief
    • helps prevent infection
    • cools burn on contact

    Sprays at an angle!

    Burns Happen. Be Prepared.™

    Net Wt. 3 oz (85 g)

    Drug Facts Panel

    First Degree Burn Spray Bottle Label

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    FIRST DEGREE BURN 
    benzocaine, triclosan spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24330-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24330-111-8589 mL in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/01/2013
    Labeler - The Akshay Wellness Group, Inc. (802294863)
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