FLAVOBAC HEALTH GUARD COMPLETE- mouth spray against sore throat pain irritation spray

Flavobac Health Guard Complete by

Drug Labeling and Warnings

Flavobac Health Guard Complete by is a Otc medication manufactured, distributed, or labeled by Laboratoires MSP Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Menthol 0.02%................Anesthetic/Analgesic

Glycerin 10%...........................Oral Demulcent

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

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.

STOP USE

sore mouth symptoms do not improve in 7 days

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

bioflavonoids, xylitol, polysorbate 20, disodium phosphate, ethanol, orange flavor, potassium sorbate, stevia, sodium hyaluronate, sucralose, purified water

Package Label - Principal Display Panel

59 mL NDC: 77982-121-11

INGREDIENTS AND APPEARANCE

FLAVOBAC HEALTH GUARD COMPLETE 
mouth spray against sore throat pain irritation spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77982-121
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.02 mg  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	10 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
XYLITOL (UNII: VCQ006KQ1E)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
STEVIA LEAF (UNII: 6TC6NN0876)
ALCOHOL (UNII: 3K9958V90M)
ORANGE (UNII: 5EVU04N5QU)
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
WATER (UNII: 059QF0KO0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77982-121-11	1 in 1 BOX	05/14/2021
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/14/2021

Labeler - Laboratoires MSP Inc (251046124)