365 Whole Foods Market Antigingivitis Mouthwash

Manufacturer
Whole Foods Market, Inc.
Effective date
2022-12-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:45:10

Label at a glance#

Product365 Whole Foods Market Antigingivitis Mouthwash
Active ingredientTHYMOL, EUCALYPTOL, MENTHOL, METHYL SALICYLATE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Vigorously swish 20mL of rinse between your teeth twice a day for 30 seconds and then spit out. • Do not swallow the rinse • Children under 12 years of age: do not use/consult a doctor.

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

• Stop use and ask a dentist if • Gingivitis, bleeding, or redness persists for more than 2 weeks. • You have painful of swollen gums, pus from the gum line, loose teeth, or increasing spacing between teeth. These may be signs or symptoms of periodontitis, a serious from of gum disease.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

OTC - PURPOSE SECTION

Helps remove plaque that leads to gingivitis, an early form of gum disease.

INDICATIONS & USAGE SECTION

Adults and children 12 years of age and older: Vigorously swish 20mL of rinse between your teeth twice a day for 30 seconds and then spit out. • Do not swallow the rinse • Children under 12 years of age: do not use/consult a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients water, ethyl alcohol (21.6% v/v), sorbitol, flavor, cocamidopropyl betaine, citric acid, stevia rebaudiana leaf extract, sodium citrate, sodium benzoate, mentha piperita (peppermint) oil, mentha spicata (spearmint) oil.

RECENT MAJOR CHANGES SECTION

Highlights

Dosage and Administration 24 Jan 2022

Indications and Usage 24 Jan 2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRODUCT LABELPRODUCT LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42681-0037-12024-01-30C16284748780-11030e365-2164-111a-e063-dadaa90a10e2WFM PLD Listing - Mouthwash WITHOUT Fluoride

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42681-003742681-0037-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
ef3f6147-7bca-37cf-e053-2995a90ab817d65bac3c-6656-be4e-e053-2995a90a4aa62022-12-07WarningsExact identifier
spl id: ef3f6147-7bca-37cf-e053-2995a90ab817
spl set id: d65bac3c-6656-be4e-e053-2995a90a4aa6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.