Rexall Liquid
FDA Label NDC 55910-346

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rexall for the product Rexall (NDC 55910-346). 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 active ingredient, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzocaine 20.0% ..................................Purpose: Oral pain reliever

Uses

Temporarily relieves pain associated with the following mouth irritations  toothache sore gums canker sores braces minor dental procedures

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

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage
  • Do not use more than directed for more than 7 days unless directed by a dentist or doctor.

    • Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, swelling, rash or fever develops, irritation, pain or redness persists or worsens swelling rash or fever developes

Directions

Adults and children 2 years of age and older:

  • apply to affect4ed area using applicator tip
  • 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: ask a dentist or doctor.

Other Information

Do not use if package has been opened

Store at 20-25°C (68-77°F)

Inactive Ingredients

Benzyl Alcohol, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, FD&C Yellow 5, Methylparaben, Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

Dosage & Administration

Adults and children 2 years of age and older:
apply to affect4ed area using applicator tip
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: ask a dentist or doctor.

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