Oral Gel
FDA Label NDC 27293-012

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 Oral Gel (NDC 27293-012). 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 IngredientBenzocaine 20%

Otc - Purpose

PurposeAnesthetic

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 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:
  • cut open tip of tube
  • apply to the 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, 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 box or see crimp of tube

Inactive Ingredient

Inactive Ingredients Purified water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Carbomer, Sorbic Acid, Methylparaben, Propylparaben, FDC Yellow 5, FDC Red 40

Package Label.Principal Display Panel

Package Label

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