Label: BENZOCAINE AND TRICLOSAN- first aid spray aerosol, spray

  • NDC Code(s): 56104-005-03
  • Packager: Premier Brands of America Inc.
  • 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 December 31, 2015

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient

    Benzocaine 20%
    Triclosan 0.13%

  • ​ ​Purpose

    External analgesic
    Antimicrobial

  • Uses

    temporary relieves pain and itching associated with:

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only.

    ​Flammable:

    Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF

    Ask a doctor before use if you

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • avoid contact with the eyes
    • do not apply over large area of the body
    • use only as directed

    Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

    ​Stop use and ask a doctor if

    • conditions worsens
    • symptoms persists 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

    • adults and children 2 years and older: clean the affected area; hold can 4" to 6" from skin; spray on affected area not more than 3 to 4 times daily
    • may cover with a sterile bandage; if so, let dry first
    • to apply to face, spray in palm of  hand and gently apply
    • children under 2 years: ask a doctor

  • ​Other information

    store between 20º and 25ºC (68ºF and 77º)

  • ​Inactive ingredients

    diisopropyl adipate, isobutane, propylene glycol, SD alcohol 40 (35%w/w), tocopheryl acetate (vitamin E acetate)

  • ​ ​Questions?

    call 1-866-964-0939

  • ​Principal Display Panel

    Premier

    First Aid Spray
    Maximum Strength

    Benzocaine 20% / Triclosan 0.13%

    • External analgesic pain & itch relief spray
    • For minor burns, cuts, scrapes & insect bites

    Net WT 3 OZ (127 g)

    PB First Aid.jpg

  • INGREDIENTS AND APPEARANCE
    BENZOCAINE AND TRICLOSAN 
    first aid spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE17 g  in 85 g
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.11 g  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-005-0385 g in 1 CANISTER; Type 0: Not a Combination Product01/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2013
    Labeler - Premier Brands of America Inc. (080051232)