FDA Label for Chloraseptic
View Indications, Usage & Precautions
Chloraseptic Product Label
The following document was submitted to the FDA by the labeler of this product Prestige Brands Holdings, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each Lozenge)
Benzocaine 6 mg
Menthol 10 mg
Purpose
Oral pain reliever
Oral pain reliever
Uses
Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth.
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 or give to children under 6 years of age unless directed by a doctor.
Do Not Use
- for teething
- in children under 6 years of age
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 health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- Adults and children 6 years of age and older: 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.
Other Information
- Store between 15○ - 30○C (59○ - 86○F)
- Protect from moisture
- Check expiration date before using
Inactive Ingredients
corn syrup, FD&C red no. 40, FD&C yellow no. 6, flavor, glycerin, propylene glycol, soy lecithin, sucrose, water
Questions?
1-800-552-7932 or Chloraseptic.com
Principal Display Panel
Chloraseptic®
Menthol | Benzocaine Oral Pain Reliever Lozenges
Citrus | 18 lozenges
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