Budpak Oral Maximum Strength
FDA Label NDC 27293-019

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Budpak Inc. for the product Budpak Oral Maximum Strength (NDC 27293-019). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Benzocaine 20%

Otc - Purpose

Purpose

Anesthetic

Indications & Usage

Uses

for the temporary relief of pain associated with:

  • toothache
  • canker sores
  • cold sores
  • fever blisters
  • minor dental procedures

Warnings

Warnings

  • do not use for more than 7 days unless directed by a dentist or a doctor
  • if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics

Otc - When Using

When using this product

  • avoid contact with the eyes
  • do not exceed recommended dosage

Otc - Stop Use

Stop using this product and ask a doctor

  • sore mouth symptoms do not improve in 7 days
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

adults and children 2 years of age and older:

  • break seal on tube
  • apply to the affected area up to 4 times daily or as directed by a dentist or a doctor
  • children under 12 years of age should be supervised in the use of the product
  • children under 2 years of age, there is no recommended dosage except under the advice and supervision of a dentist or a doctor

Other

Other Information

  • store at room temperature.
  • Lot. No and Exp. Date: see crimp of tube.

    • PRINCIPAL DISPLAY PANEL

    ORAL MAXIMUM STRENGTH PAIN RELIEF GEL

    Benzocaine 20%

    Anesthetic

    NET WT 0.5 OZ (14 g)

Inactive Ingredient

Inactive Ingredients

Ammonium Glycyrrhizate, Polyethylene glycol, Saccharin sodium, Sorbic acid, Flavor

Package Label.Principal Display Panel

Image Of Package Label (Oral Maximum Gel)

Image Of Package Label (Oral Maximum Gel)

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