Oral Science-ColdFlu Spray updated label

Manufacturer
Oral Science Inc
Effective date
2022-10-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:51:17

Label at a glance#

ProductFlavobac Health Guard Complete
Active ingredientMENTHOL, GLYCERIN
Label structure12 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

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

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

Purpose

OTC - PURPOSE SECTION

Anesthetic/Analgesic

Oral Demulcent

Use

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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 SECTION

try to avoid swallowing spray

PREGNANCY SECTION

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

OTHER SAFETY INFORMATION

Do not exceed the recommended dosage.

OTC - STOP USE SECTION

sore mouth symptoms do not improve in 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81359-121-112023-07-28C16284748780-10191ceaa-61a5-198a-e063-dbdaa90aec3eOral Science-ColdFlu Spray updated label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81359-121-11Flavobac Health Guard Complete59 mL in 1 BOTTLESPRAY592
81359-121-11Flavobac Health Guard Complete1 in 1 BOXSPRAY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81359-121FLAVOBAC HEALTH GUARD COMPLETE (MOUTH SPRAY AGAINST SORE THROAT PAIN IRRITATION) SPRAY [ORAL SCIENCE INC]2Legacy NDC, 2 package rows20221030_c23afe99-807e-e9cf-e053-2a95a90ae239.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81359-12181359-121-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ec2ef246-53a7-7a70-e053-2a95a90ae657c23afe99-807e-e9cf-e053-2a95a90ae2392022-10-29WarningsExact identifier
spl id: ec2ef246-53a7-7a70-e053-2a95a90ae657
spl set id: c23afe99-807e-e9cf-e053-2a95a90ae239