Orasep Liquid
FDA Label NDC 54859-504

Full FDA labeling including 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 54859-504). 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, warnings, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients:

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

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

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



Otc - Purpose

Uses:

  • For temporary relief of ocassional minor sore thoat pain and dry, scratchy throat.
  • For the temporary relief of pain associated with canker sores, minor irritation or injury of the mouth and gums, minor dental procedures, minor irritations caused by dentures or  orthodontic appliances.
  • For temporary relief of sore gums due to teething in infants and children 4 months of age and older.

Warnings

 Warnings:

  Do not exceed recommended dosage.

Otc - Do Not Use

Do not use in or near eyes.

  • Ifsore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a physician promptly.
  • If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentist or physician promptly.
  • Fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your physician.
    • DO NOT USE: If you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Otc - Keep Out Of Reach Of Children

Keep 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 Chlidren 6 years and over: Spray Orasep several times to affected area in mouth or lips. Do not use more than 4 times a day. Children under 12 years of age should be supervised in the use of this product. Children under 6 years of age: Consult a physician. For sore gums associated with teething, spray a small amount on finger and rub on the gum after you wash your hands.

As a gargle or mouthwash, Adults and Children 12 years and over, place 1/2 teaspoon (2.5 ml) in 1/2 glass of warm water several times a day. Do not use more than 4 times a day.

Indications & Usage

In the event of accidental contact with eyes, flush immediately with water and continuously for 10 minutes. Sek immediate medical attention if pain persists.

Other Information: Tamper Evident Feature: Do not use if heat seal under cap is torn, broken or missing. Store at controlled room temperature 15-30 degree celcius ( 59-86 degree fahrenheit).

Inactive Ingredient

Inactive Ingredients: Castor oil (Partially Hydrogenated), Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Saccharin Sodium.

Otc - Questions

Questions or comments? 1-866-595-5598

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