Label: LEADER ORAL PAIN RELIEF ANESTHETIC- benzocaine 20% 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 August 24, 2012

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  • Active Ingredient

    Benzocaine, 20%

  • Purpose

    Oral pain reliever

  • Uses

    For the temporary relief of minor toothache, pain and sore mouth associated with canker sores, dentures and orthodontic appliances.

  • WARNINGS

    Warnings

  • INDICATIONS & USAGE

    Allergy Alert: do not use this product if you have a history of allergy 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 dentist or doctor.
  • STOP USE

    Stop use and ask a Doctor if:

    • swelling, rash, or fever develops
    • irritation, pain or redness persists or gets worse
  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Cut open tip of tube.

    Adults and children 2 years of age and older, apply to affected area up to 4 times daily or as directed by a dentist or doctor.

    Children under 12 years of age should be supervised in the use of the product.

    Children under 2 years of age, consult a doctor.

  • Other Information

    • Do not use if tube tip is cut prior to opening.
    • Store at room temperature.
  • Inactive Ingredients

    Flavors, PEG 4, PEG 540, PEG 75, PEG 8, Sodium Saccharin, Sorbic Acid.

  • PRINCIPAL DISPLAY PANEL

    Maximum Strength

    Oral Pain Relief

    Anesthetic Gel

    ORAL PAIN RELIVER

    BENZOCAINE 20%

    0.5OZ (14.2G)

    carton imageimage of carton lable

  • PRINCIPAL DISPLAY PANEL

    Maximum Strength

    Oral Pain Relief

    Anesthetic Gel

    ORAL PAIN RELIVER

    BENZOCAINE 20%

    0.5OZ (14.2G)

    tube imageimage of tube lable

  • INGREDIENTS AND APPEARANCE
    LEADER ORAL PAIN RELIEF  ANESTHETIC
    benzocaine 20% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-607
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    Sorbic Acid (UNII: X045WJ989B)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-607-061 in 1 CARTON
    1NDC:37205-607-0514.2 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35608/08/2012
    Labeler - Cardinal Health (097537435)
    Registrant - Lee Pharmaceuticals (056425432)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cardinal Health097537435label(37205-607)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lee Pharmaceuticals056425432pack(37205-607)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack009248480manufacture(37205-607)
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