Llorens- Orasep Liquid 503

Llorens- Orasep Liquid 503
SPL v6
SPL
SPL Set ID ed70911b-9da8-4e1d-97fa-66b18d28516a
Route
TOPICAL
Published
Effective Date 2020-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (2 mg) Menthol (0.5 mg) Cetylpyridinium (0.1 mg)
Inactive Ingredients
Castor Oil Methylparaben Propylene Glycol Propylparaben Water Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-04-01

Description

Active Ingredients: Benzocaine...................... 2%      Anesthetic Menthol.................................0.5%       Anesthetic Cetylpyridinium Chloride..........0.1% Antiseptic


Medication Information

Warnings and Precautions

 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.

Indications and 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.
Dosage and 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.
Description

Active Ingredients: Benzocaine...................... 2%      Anesthetic Menthol.................................0.5%       Anesthetic Cetylpyridinium Chloride..........0.1% Antiseptic

Section 50565-1

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.

Section 51727-6

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

Section 51945-4

Section 53413-1

Questions or comments? 1-866-595-5598

Section 53414-9

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

Section 55105-1

Purpose

Oral anesthetic

Oral antiseptic

Section 55106-9

Active Ingredients:

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

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

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


Structured Label Content

Indications and Usage (34067-9)

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.
Dosage and Administration (34068-7)

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.
Warnings and Precautions (34071-1)

 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.

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 1-866-595-5598

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Oral anesthetic

Oral antiseptic

Section 55106-9 (55106-9)

Active Ingredients:

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

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)