Spotlight Mouthwash for Whitening Teeth

Manufacturer
Oral Spotlight Care Inc
Effective date
2023-01-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:39:59

Label at a glance#

ProductSpotlight Mouthwash for Whitening Teeth
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient  Sodium Fluoride 0.05%

OTC - PURPOSE SECTION

Purpose  Anticavity

INDICATIONS & USAGE SECTION

Use  aids in the prevention of dental cavities

WARNINGS SECTION

Warnings
Some people may experience tooth sensitivity or gum

discomfort when using whitening products.  This discomfort is

temporary and not harmful.  If you experience more than mild

tooth sensitivity, stop use and consult your dentist or doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If more than used for rinsing

is accidentally swallowed, get medical help or contact a

Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
■ adults and children 12 years of age and older:
■ use twice 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

habits (to minimize swallowing).
■ supervise children as necessary until capable of using without supervision
■ children under 12 years of age: consult a dentist or doctor

OTHER SAFETY INFORMATION

Other information ■ store at room temperature

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Glycerin, Water, Xylitol, Hydrogen Peroxide, Poloxamer 407,

Sodium Saccharin, Carrageenen, Glycolipids, Mentha

Piperita (peppermint) oil , Sodium Benzoate

OTC - QUESTIONS SECTION

Questions?  +1 (646) 9806461

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Spotlight

Oral Care

CREATED BY DENTISTS

       W

  Mouthwash

for Whitening

     Teeth

Peppermint Flavor

NET WT. 16.9 fl oz (500 mL)

MADE IN THE USA

Spotlight Oral Care, 90 South Dale, Suite #8

Saint Paul, Minnesota, USA 55102

001 MWash001 MWash

res

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75065-00175065-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
dc196a56-98a8-4125-966b-2c6c84011f5264328e9f-ede7-42c5-a604-2983ffcd69182023-01-18WarningsExact identifier
spl id: dc196a56-98a8-4125-966b-2c6c84011f52
spl set id: 64328e9f-ede7-42c5-a604-2983ffcd6918

Reported adverse events (FAERS/openFDA)#

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