Mouthwash for Gum Health

Manufacturer
Oral Spotlight Care Inc
Effective date
2023-11-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:20:24

Label at a glance#

ProductMouthwash for Gum Health
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.05% (.02% w/v fluoride ion)

OTC - PURPOSE SECTION

Purpose  Anticavity

INDICATIONS & USAGE SECTION

Use  aids in the prevention of dental cavities.

WARNINGS SECTION

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If more than used is accidentally swallowed, get

medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
• Adults and children 6 years of age and older:
• Use once a day after brushing your teeth with a toothpaste.
• Vigorously swish 10 milliliters (2 teaspoonfuls) of rinse between your
teeth for 1 minute and then spit out.
• Do not swallow the rinse.
• Do not eat or drink for 30 minutes after rinsing.
• Instruct children under 12 years of age in good rinsing
habits (to minimize swallowing).
• Supervise children as necessary until capable of using
without supervision
• Children under 6 years of age: Consult a dentist or doctor

OTHER SAFETY INFORMATION

Other information • Store at room temperature.

INACTIVE INGREDIENT SECTION

Inactive ingredients
Deionized Waler, Glycerin, Xylital, Sorbitol, Poloxamer 407,
Glycolipid, Mentha Arvensis (peppemint) Oil, Xanthan Gum,
Potassium Sorbate, Carrageenan, Sodium Benzoate, Sodium
Saccharin, Carthamus Tinctorius, Allantoin, Beta Vulgaris,
Spirulina Maxima

OTC - QUESTIONS SECTION

Questions?  +1 (646) 9806461

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Spotlight®

Oral Care

CREATED BY DENTISTS

       G

Mouthwash
for Gum Health

Aids in Relieving Symptoms
of Bad Breath, Inflamed
& Bleeding Gums

-- Active Ingredient --
  Sodium Fluoride

--- Alcohol Free --

Anticavity Fuoride Mouthwash

Peppermint Flavor

IMPORTANT: Read directions for proper use.

NET WT.  16.9 fl oz (500mL)

MADE IN THE USA

Spotlight Oral Care, 90 South Dale, Suite #8,

Saint Paul, Minnesota, USA 55102

002 MWash002 MWash

res

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75065-00275065-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
b7d9ebe5-beef-4753-97ba-082c9599876604fab543-e6dd-4f34-9f22-e39e86abb6bd2023-11-19WarningsExact identifier
spl id: b7d9ebe5-beef-4753-97ba-082c95998766
spl set id: 04fab543-e6dd-4f34-9f22-e39e86abb6bd

Reported adverse events (FAERS/openFDA)#

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