Chloraseptic Green Tea Lozenges

Chloraseptic Green Tea Lozenges
SPL v14
SPL
SPL Set ID 7c161a17-cf82-4de3-8348-888c040df0f9
Route
ORAL
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (15 mg)
Inactive Ingredients
Corn Syrup Epigallocatechin Gallate Fd&c Blue No. 1 Fd&c Yellow No. 5 Honey Propylene Glycol Lecithin, Soybean Sucrose Glycerin Water

Identifiers & Packaging

Pill Appearance
Imprint: C Shape: oval Color: green Color: yellow Size: 4 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-01-01

Description

[ Chloraseptic © Warming Sore Throat Lozenges – Honey ] Drug Facts

Purpose

Oral Anesthetic/Analgesic


Medication Information

Purpose

Oral Anesthetic/Analgesic

Description

[ Chloraseptic © Warming Sore Throat Lozenges – Honey ] Drug Facts

Uses

Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth

Other
  • Store between 15ºC - 30ºC (59ºF and 86ºF)  

  • Protect from moisture.

  • Check expiration date before using.

  • Contains FD&C yellow no. 5 (tartrazine) as a color additive.
Active

(in each lozenge)

Benzocaine 15 mg

Section 42229-5

[ Chloraseptic © Warming Sore Throat Lozenges – Honey ]

Drug Facts

Inactive

corn syrup, FD&C yellow no. 5, flavor, glycerin, honey, propylene glycol, soy lecithin, sucrose, water

Warnings

Methemoglobinemia warning:   

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces 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)  

∙ headache  

∙ rapid heart rate  

∙ shortness of breath  

∙ dizziness or lightheadedness  

∙ fatigue or lack of energy  

Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics. If a skin reaction occurs, stop use and seek medical help right away.

Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days unless directed by a doctor.

Directions
  • Adults and children   6 years of age and over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.

  • Children under   6 years of age: Do not use.
Questions?

1-800-552-7932 Chloraseptic.com

Do Not Use: 
  • for teething  

  • in children under 6 years of age 
Principal Display Panel



Chloraseptic © Warming Sore Throat Lozenges

Benzocaine Oral Anesthetic | Analgesic


18 lozenges | Honey Lemon

Keep Out of Reach of Children.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Stop Use and Ask A Dentist Or Doctor If
  • sore mouth symptoms do not improve in 7 days

  • irritation, pain or redness persists or worsens

  • swelling, rash or fever develops

Structured Label Content

Uses

Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth

Other
  • Store between 15ºC - 30ºC (59ºF and 86ºF)  

  • Protect from moisture.

  • Check expiration date before using.

  • Contains FD&C yellow no. 5 (tartrazine) as a color additive.
Active

(in each lozenge)

Benzocaine 15 mg

Section 42229-5 (42229-5)

[ Chloraseptic © Warming Sore Throat Lozenges – Honey ]

Drug Facts

Purpose

Oral Anesthetic/Analgesic

Inactive

corn syrup, FD&C yellow no. 5, flavor, glycerin, honey, propylene glycol, soy lecithin, sucrose, water

Warnings

Methemoglobinemia warning:   

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces 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)  

∙ headache  

∙ rapid heart rate  

∙ shortness of breath  

∙ dizziness or lightheadedness  

∙ fatigue or lack of energy  

Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics. If a skin reaction occurs, stop use and seek medical help right away.

Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days unless directed by a doctor.

Directions
  • Adults and children   6 years of age and over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.

  • Children under   6 years of age: Do not use.
Questions?

1-800-552-7932 Chloraseptic.com

Do Not Use:  (Do not use: )
  • for teething  

  • in children under 6 years of age 
Principal Display Panel (PRINCIPAL DISPLAY PANEL)



Chloraseptic © Warming Sore Throat Lozenges

Benzocaine Oral Anesthetic | Analgesic


18 lozenges | Honey Lemon

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Stop Use and Ask A Dentist Or Doctor If (Stop use and ask a dentist or doctor if)
  • sore mouth symptoms do not improve in 7 days

  • irritation, pain or redness persists or worsens

  • swelling, rash or fever develops

Advanced Ingredient Data


Raw Label Data

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