Active Ingredients (In Each Lozenge)
Benzocaine 6 mg
Menthol 10 mg
Chloraspetic Lozenge
FDA Label NDC 67172-023
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 Chloraspetic (NDC 67172-023). 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 ingredients (in each lozenge), purpose, uses, warnings, do not use, when using this product, stop use and ask a dentist or doctor if:, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral pain reliever
Oral pain reliever
Uses
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. 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 care 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
- Contains FD&C yellow no. 5 (tartrazine) as a color additive.
- Store between 15○C - 30○C (59○F - 86○F)
- Protect from moisture.
- Check expiration date before using.
Inactive Ingredients
corn syrup, FD&C yellow no. 5, glycerin, honey, propylene glycol, soy lecithin, sucrose, water
Questions
1-800-552-7932 Chloraseptic.com
Principal Display Panel
Chloraseptic®
Sore throat
18 lozenges | Honey Lemon With real honey
Principal Display Panelchloraseptic®sore Throat18 Lozenges | Honey Lemon With Real Honey (Chloraspetic Honey Lemon Lozenge 01)
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