Label: LEADER ORAL ANALGESIC- benzocaine gel

  • 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 July 7, 2017

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  • ACTIVE INGREDIENT

    Active ingredient                                                                Purpose

    Benzocaine 20%................................................................Oral Pain Reliever

  • PURPOSE

    Uses

    • temporarily relieves pain due to toothache, canker sores, cold sores, fever blisters, minor irritation of the mouth and gums cause by dentures or orthodontic appliances
  • WARNINGS

    Warnings

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

  • DO NOT USE

    Do not use

    • more than directed
    • for more than 7 days unless directed by a doctor/dentist
  • STOP USE

    Stop use and ask a doctor 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

    Keep out of reach of children.

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

  • INDICATIONS & USAGE

    Directions

    • remove cap and cut tip of tube on score mark
    • adults and children 2 years of age and older: apply a small amount of Oral Analgesic Gel to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a doctor or dentist
    • children under 12 years of age: should be supervised when using this product
    • children under 2 years of age: ask a doctor/dentist
  • STORAGE AND HANDLING

    Other information

    • store at 15o to 25oC (59o to 77oF)
    • do not use if tube tip is cut prior to opening
    • this preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist can be consulted
    • do not use continuously
    • Lot no and Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    d-sorbitol solution, flavor, glycerin, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium hydrate

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    www.myleader.com

    1-800-200-6313

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LEADER ORAL ANALGESIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-122
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-122-121 in 1 CARTON10/11/2016
    111.9 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B05/01/2012
    Labeler - CARDINAL HEALTH (097537435)
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