Label: TOPICALE- benzocaine patch

  • NDC Code(s): 10733-173-01
  • Packager: Medical Products Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

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  • Active Ingredient
    Benzocaine 18%
  • PURPOSE
    Oral Anesthetic
  • INDICATIONS & USAGE
    For the temporary relief of minor pain and irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedures, minor irritation of the mouth and gums caused by ...
  • 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 ...
  • DOSAGE & ADMINISTRATION
    Do not use more than directed. Adults and children 12 years or older - Apply to the affected area. Allow to remain in place at least one minute and the spit out. Use up to 4 times daily or as ...
  • OTHER SAFETY INFORMATION
    Store at 68º to 77º F (20º - 25º C)
  • INACTIVE INGREDIENT
    Benzalkonium Chloride (as a preservative), Gelatin Hydrolysate, Glycerin, Flavorings,FD&C Blue Dye # 1, FD&C Yellow Dye # 5, Mineral Oil, Purified Water
  • INFORMATION FOR OWNERS/CAREGIVERS
    NDC 10733-173-01 - Premier - Topicale GelPatch - Oral Anesthetic Suspension - Benzocaine, 18 % REF 9007149 Contains: 25 - 0.2gm Packets - Mint - Made in U.S.A. Manufactured for: Premier® Dental ...
  • PRINCIPAL DISPLAY PANEL
    film ...
  • INGREDIENTS AND APPEARANCE
    Product Information