Label: INSTANT TOOTHACHE PAIN RELIEF - benzocaine liquid

  • NDC Code(s): 59779-831-21, 59779-831-29
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/11

If you are a consumer or patient please visit this version.

  • Active ingredient

    Benzocaine 20.0%  ...................................................................... Oral pain reliever Close
  • Use

    for the temporary relief of pain due to toothaches
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  • WARNINGS

    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

    Flammable: Keep away from flame or fire. Avoid smoking during application and until product has dried

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

    Stop use and ask a doctor - if swelling, rash or fever develops - irritation, pain or redness persists or worsens

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

    Center right away.

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  • Directions

    do not use if package has been opened - adults and children 2 years of age and
    older:
    using applicator tip, apply to the cavity and around the gum surrounding the teeth. Use up to 4
    times daily or as directed by a dentist or doctor. Children 12 years of age should be supervised in
    the use of this product. - children under 2 years of age: ask a dentist or doctor
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  • Other Information

    This preparation is intended for use in cases of toothache, only as a
    temporary expedient until a dentist can be consulted. Do not use continiously.
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  • Inactive ingredients

    Ethyl Alcohol 44.2% by weight, Red 40, Yellow 5, Flavor,
    Polyethylene Glycol, Water, Sodium Saccharin
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  • DOSAGE & ADMINISTRATION

    • use 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 this product • children under 2 years of age: consult a dentist or doctor Close
  • INGREDIENTS AND APPEARANCE
    INSTANT TOOTHACHE PAIN RELIEF 
    benzocaine liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-831
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 20 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL 41.99 g  in 100 g
    POLYETHYLENE GLYCOL 400 34.5 g  in 100 g
    SACCHARIN SODIUM 0.5 g  in 100 g
    FD&C RED NO. 40 0.001 g  in 100 g
    FD&C YELLOW NO. 5 0.002 g  in 100 g
    WATER 2.507 g  in 100 g
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor COCONUT (Pina Colada Flavor #26041) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-831-29 1 in 1 CARTON
    1 NDC:59779-831-21 14.17 g in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 10/01/2009
    Labeler - CVS Pharmacy (062312574)
    Registrant - Lornamead (126440440)
    Establishment
    Name Address ID/FEI Business Operations
    Lornamead 126440440 manufacture, pack
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