Active Ingredient(S)
Menthol 0.04%................Anesthetic/Analgesic
Glycerin 10%...........................Oral Demulcent
Flavobac Health Guard Complete
FDA Label NDC 77982-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Msp Inc for the product Flavobac Health Guard Complete (NDC 77982-111). 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(s), purpose, use, warnings, otc - when using, pregnancy, other safety information, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anesthetic/Analgesic
Oral Demulcent
Use
temporary relief of occasional minor irritation, pain, sore mouth, sore throat, minor discomfort and protection of irritated areas in sore mouth and sore throat
Warnings
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
Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days
If pregnant or breast-feeding, ask a health professional before use
Keep out of the reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Do not exceed the recommended dosage. When using this product, try to avoid swallowing spray
Otc - When Using
try to avoid swallowing spray
Pregnancy
If pregnant or breast-feeding, ask a health professional before use
Other Safety Information
Do not exceed the recommended dosage.
Otc - Stop Use
sore mouth symptoms do not improve in 7 days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
adults and children 2 years of age and older: apply 4 sprays to the affected area. Gargle, swish around, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor
children under 12 years of age: should be supervised in the use of this product
children under 2 years of age: not recommended
Inactive Ingredients
Water, bioflavonoids, xylitol, polysorbate 20, disodium phosphate, ethanol, mint flavor, potassium sorbate, stevia, sodium hyaluronate
Package Label - Principal Display Panel
59 mL NDC: 81359-111-11
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