Orasep
FDA Label NDC 54859-503

10 label sections · Submitted to the FDA by Llorens Pharmaceutical International Division · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Llorens Pharmaceutical International Division for the product Orasep (NDC 54859-503). 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 - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredients:

Benzocaine...................... 2%      Anesthetic

Menthol.................................0.5%       Anesthetic

Cetylpyridinium Chloride..........0.1% Antiseptic

Otc - Purpose

Purpose

Oral anesthetic

Oral antiseptic

Indications & Usage

Uses for temporary relief of:

  • Occasional minor sore throat pain and dry scratch throat.
  • Pain due to canker sores. Pain due to minor irritation or injury of the mouth and gums. Pain due to minor dental procedures, minor irritations cause by dentures or orthodontic appliances.

Warnings

 Warnings:

Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other 'caine' anesthetics.

Sore throat warning: If sore throat is sever, persists for more than2 days, is accompanied or followed by fever, headache, rash, nausea, or vomitings, consult a doctor promptly. 

Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persist or worsens.

Do not exceed recommended dosage.

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding,ask a health professional before use.

Dosage & Administration

Directions: 

  • Adults and children 6 years of age or older: Using a q-tip apply the solution to the affected area. Use up to 4 times daily or as directed by a doctor or dentist. 
  • Children under 6 years of age: ask a doctor or dentist.

Inactive Ingredient

Inactive Ingredients: Artificial and natural flavors, methylparaben, polyoxyl hydrogenated castor oil, propylene glycol, propylparaben, purified water, and sucralose.

Otc - Questions

Questions or comments? 1-866-595-5598

Package Label.Principal Display Panel

Orasepsollabel (Orasepsolution)

Orasepsollabel (Orasepsolution)

* Please review the disclaimer below.