Onral Oral Pain Reliever Mouthwash Liquid
FDA Label NDC 85454-0421

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Syka Pharma Inc. for the product Onral Oral Pain Reliever Mouthwash (NDC 85454-0421). 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, methemoglobinemia warning:, stop use and seek immediate medical attention, 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 5%

Purpose

Oral Pain Reliever

Uses

For the temporary relief of minor irritation, pain, sore mouth, and sore throat.

Warnings

If sore throat is severe, persists for more than 2 days, is accompanied, or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentists or doctor promptly.

  • Do not exceed recommended dosage.

Do Not Use

  • this product if you have a history of allergy to local anesthetics such as procaine, butacaine, or other "caine" anesthetics.

Methemoglobinemia Warning:

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduce the amount of oxygen carried in blood. This can occur even if you have used this product before.

Stop Use And Seek Immediate Medical Attention

if you or a child in your care develops:

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

Keep Out Of Reach Of Children

Directions

  • Shake well upside down.
  • Gargle, swish around in the mouth, or allow to remain in place for at least 1 minute and then spit out.
  • Children under 12 years of age should be supervised in the use of the product.
  • Apply to the affected area.
  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Do not use for teething.
  • Children under 2 years of age: Do not use.

Other Information

store at 68-77 ° F (20-25 ° C)

Inactive Ingredients:

Purified water, Vegetable glycerin, PEG 400, Sorbitol, Polysorbate 80, Natural orange flavor, Potassium sorbate, Xanthan gum, Citric acid, Beta-carotene.

Package Labeling:

Label (Label)

Label (Label)

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