Label: ORAL PAIN RELIEF- benzocaine gel

  • NDC Code(s): 57896-139-05
  • Packager: GERI-CARE PHARMACEUTICAL CORP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 31, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzocaine 20%

  • Purpose

    Oral anesthetic

  • Uses

    temporary relieves pain associated with the following mouth
    and gum irritations: • toothache • sore gums • canker
    sores • braces • minor dental procedures • dentures

  • Warnings

    METHEMOGLOBINEMIA WARNING:
    Use of this product may cause methemoglobinemia, a
    serious condition that must be treated promptly because it
    reduces the amount of oxygen carried in blood. This can
    occur even if you have used this product before. Stop use
    and seek immediate medical attention if you or a child in
    your care develops:
    • pale, gray, or blue colored skin (cyanosis)
    • headache
    • rapid heart rate
    • shortness of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy

    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. If a skin reaction occurs, stop use and seek medical help right away.

    Do not use

    • for teething

    • in children under 2 years of age

    • more than recommended
    • for more than 7 days unless told to do so by a dentist or doctor

    When using this product

    • avoid contact with the eyes

    Stop use and ask a doctor if

    • sore mouth symptoms do not improve in 7 days

    • irritation, pain, or redness persists or worsens

    • swelling, rash or fever develops

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • do not exceed recommended dosage

    • do not use for more than 7 days unless told to do so by a dentist or doctor

    • adults and children 2 years of age or older: apply to affected area up to 4 times daily or as directed by doctor/dentist
    • children between 2 and 12 years of age: adult supervision should be given in use of this product
    • children under 2 years of age: do not use

  • Other information

    • do not use tube if it is cut prior to opening

    • to open tube, cut open tip of tube on score mark with scissors
    • store at a controlled room temperature 68º-77ºF (20º-25ºC)

  • Inactive ingredients

    Flavor, PEG-6, PEG-8, PEG-32, PEG-75, Sodium Saccharin, Sorbic Acid

  • Questions or Comments?

    1-800-540-3765

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ORAL PAIN RELIEF 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-139
    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
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-139-051 in 1 CARTON03/01/2021
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02203/01/2021
    Labeler - GERI-CARE PHARMACEUTICAL CORP (611196254)
    Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)
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