LUCKY ORAL PAIN RELIEF (BENZOCAINE BENZALKONIUM CHLORIDE) GEL [DELTA BRANDS INC]

LUCKY ORAL PAIN RELIEF (BENZOCAINE BENZALKONIUM CHLORIDE) GEL [DELTA BRANDS INC]
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NDC 20276-561-14
Set ID 5dbfa3ae-2994-45d5-b799-a2638d87d9e8
Category HUMAN OTC DRUG LABEL
Packager Delta Brands Inc
Generic Name
Product Class
Product Number
Application Number PART356
  • Active Ingredient

    Benzocaine 20%

    Benzalkonium Chloride 0.1%

  • Purpose

    Oral pain reliever

    Antiseptic

  • Use

    ■ for the temporary relief of pain due to toothaches ■ to help protect against infectionin minor oral irritation

  • Warnings

    Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics

  • Do not use

    ■ more than directed ■ for more than 7 days unless directed by a physician or healthcare provider

  • Stop use and ask a physician if

    ■ swelling, rash or fever develops ■ irritation, pain or redness persists or worsens ■ symptoms do not improve in 7 days

  • Keep out of reach of children

    In case of overdose or allergic reaction get medical help or contact a Poison Control Center right away

  • Directions

    ■ adults and children 2 years of age and over: apply a small amount of the product to the cavity and around the gum surrounding the teeth Use up to 4 times daily or as directed by a physician or healthcare provider ■ children under 12 years: should be supervised in the use of this product ■ children under 2 years of age: ask a physician or health care provider

  • Other information

    ■ this preparation is intended for use in cases ot toothache, only as a temporary expedient until a physican can be consulted ■ do not use continuously ■ avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

  • Inactive ingredients

    ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    LUCKY  ORAL PAIN RELIEF
    benzocaine benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-561
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-561-1414 g in 1 TUBE; Type 0: Not a Combination Product06/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/15/2014
    Labeler - Delta Brands Inc (102672008)

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