Otc - Active Ingredient
Active Ingredients:
Benzocaine...................... 2% Anesthetic
Cetylpyridinium Chloride..........0.1% Antiseptic
Menthol.................................0.5% Anesthetic
The following Structured Product Label (SPL) was submitted to the FDA by Llorens Pharmaceutical International Division for the product Orasep (NDC 54859-504). 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.
Active Ingredients:
Benzocaine...................... 2% Anesthetic
Cetylpyridinium Chloride..........0.1% Antiseptic
Menthol.................................0.5% Anesthetic
Purpose
Oral anesthetic
Oral antiseptic
Uses for temporary relief of:
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.
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.
If pregnant or breast feeding,ask a health professional before use.
Directions:
Inactive Ingredients: Artificial and natural flavors, methylparaben, polyoxyl hydrogenated castor oil, propylene glycol, propylparaben, purified water, and sucralose.
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