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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Laboratoires MSP-Oral Science-ColdFlu Spray updated label

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

try to avoid swallowing spray

If pregnant or breast-feeding, ask a health professional before use

Do not exceed the recommended dosage.

sore mouth symptoms do not improve in 7 days

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: 81359-112-1159 mL NDC: 77982-121-11

FLAVOBAC HEALTH GUARD COMPLETE 
mouth spray against sore throat pain irritation spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77982-121
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.02 mg  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN10 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77982-121-111 in 1 BOX05/14/2021
159 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/14/2021
Labeler - Laboratoires MSP Inc (251046124)

Revised: 10/2022
Document Id: ec2ee0a5-72a5-766e-e053-2995a90a60ff
Set id: c24e71dd-abf7-68cf-e053-2995a90a8a17
Version: 2
Effective Time: 20221029
 
Laboratoires MSP Inc