Active Ingredient (In Each Lozenge)
Benzocaine 15 mg
Bactimicina For Sore Throat Lozenge
FDA Label NDC 24286-1577
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dlc Laboratories, Inc. for the product Bactimicina For Sore Throat (NDC 24286-1577). 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 (in each lozenge), purpose, use, methemoglobinemia warning:, allergy alert, sore throat warning:, do not use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral anesthetic/Analgesic
Use
temporarily relieve:
- occational minor irritation, pain, sore mouth and sore throat
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 developes:
- pale, gray, or blue colored skin (cyanosis)
- shortness of breath
- headache
- dizziness or lightheadedness
- rapid heart rate
- 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 any other "caine" anesthetics. If skin reation occurs, stop use and seek medical help right away.
Sore Throat Warning:
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.
Do Not Use
- for teething
- in children under 5 years of age
When Using This Product
- do not exceed recommended dosage
Stop Use And Ask A 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, or if more than used for pain relief is accidentally swallowed, get medical help or contact a Poison COntrol Center immediately
Directions
- adults and children 5 years of age and older:
- children under 5 years of age: do not use.
Dissolve 1 lozenge slowly in the mouth. May be repeated every 2 hours as needed or as directed by a doctor or dentist.
Other Information
- protect from moisture
- store at room temperature
- check expiration date before using
Inactive Ingredients
dextrose, FD&C yellow #6, FD&C red #40, corn syrup, hydrogenated cottonseed oil, natural and artificial flavor, propylene glycol, sucrose
Question
1-800-858-3889
Other
Distributed by
De La Cruz Products
A Division of DLC Laboratories, Inc.
Paramount, CA 90723 USA
Principle Display
Fast Acting
Trusted since 1978
New Look
Maximum Strength
Bactimicina ®
Sore Throat Pain Relief
Benzocain Oral Anesthetic
Orange Flavor
18 Lozenges
Bactimicina Lozenges (Bactimicina Lozenges Box 2021a)
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