Active Ingredient
(in each lozenge)
Benzocaine 15 mg
Chloraseptic Warming Sore Throat Lozenge
FDA Label NDC 67172-018
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prestige Brands Holdings, Inc. for the product Chloraseptic Warming Sore Throat (NDC 67172-018). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and ask a dentist or doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral Anesthetic/Analgesic
Oral Anesthetic/Analgesic
Uses
Temporarily relievesoccasional minor irritation, pain, sore throat and sore mouth
Temporarily relieves:
- occasional minor irritation, pain, sore throat and sore mouth
Warnings
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.
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 or administer to children under 3 years of age unless directed by a doctor.
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.
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 or administer to children under 3 years of age unless directed by a doctor.
When Using This Product
do not exceed recommended dosage.
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
If Pregnant Or Breast-Feeding,
ask a doctor before use.
ask a doctor before use.
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.
In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- Adults and children 3 years of age and over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.
- Children under 3 years of age: Consult a doctor or dentist.
- Adults and children 3 years of age and over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.
- Children under 3 years of age: Consult a doctor or dentist.
Other Information
- Store between 59°F and 86°F (15°C - 30°C).
- Protect from moisture.
- Check expiration date before using.
- Contains FD&C yellow no. 5 (tartrazine) as a color additive.
- Store between 59°F and 86°F (15°C - 30°C).
- Protect from moisture.
- Check expiration date before using.
- Tamper Evident: Do not use if blister package with “Chloraseptic®” name has been disturbed or opened.
Inactive Ingredients
corn syrup, FD&C yellow no. 5, flavor, glycerin, honey, propylene glycol, soy lecithin, sucrose, water
Corn Syrup, Epigallocatechin Gallate (EGCG), FD&C Blue #1, FD&C Yellow #5, Flavor, Honey, Propylene Glycol, Soy Lecithin, Sucrose, Water
Questions?
1-800-552-7932 Chloraseptic.com
Drug Facts
1-800-552-7932 or www.chloraseptic.com
Active Ingredients
(in each lozenge)
Benzocaine 15 mg
When Using This Product:
do not exceed recommended dosage.
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
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