Equate Orasol Gel
FDA Label NDC 79903-966

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc. for the product Equate Orasol (NDC 79903-966). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Benzocaine 20%

Purpose

Oral Pain Reliever

Uses

  • temporary relief of occasional minor irritation, pain and sore mouth

Warnings

Methemoglobinema Warning: Use of this product may cause Methemoglobinema, a serious condition that must be treated promptly becasue it reduces the amount of oxygem carried in the blood. This can occur even if you have used this product before. Stop use and seek immeditate medical attention if you or a child in yuor care develops;

  • pale, gray, or blue colored skin(cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

    • 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.

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

Directions

  • do not use tube if it is cut prior to opening
  • cut open tip of tube on score mark
  • use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel
  • apply to affected area up to four times daily or as directed by a dentist or physician
  • Adults and children 2 years of age and older: Apply to affected area
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 2 years of age: Consult a doctor

Inactive Ingredients

Benzyl Alcohol, Carbomer, D&C Yellow No 10, FD&C Blue No 1, FD&C Red No 40, Flavor, Glycerin, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin

Other Information

store at a controlled room temperature 68°- 77°F (20°-25°C)

Principal Display Panel

NDC 79903-966-09

Oral Pain Relief

MAXIMUM STRENGTH GEL

Benzocaine 20% NET WT. 0.33 OZ (9.35g)

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