SPOTLIGHT MOUTHWASH FOR WHITENING TEETH- sodium fluoride liquid

Spotlight Mouthwash for Whitening Teeth by

Drug Labeling and Warnings

Spotlight Mouthwash for Whitening Teeth by is a Otc medication manufactured, distributed, or labeled by Oral Spotlight Care Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient  Sodium Fluoride 0.05%

PURPOSE

Purpose  Anticavity

INDICATIONS & USAGE

Use  aids in the prevention of dental cavities

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

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

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

Inactive Ingredients

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

Sodium Saccharin, Carrageenen, Glycolipids, Mentha

Piperita (peppermint) oil , Sodium Benzoate

QUESTIONS

Questions?  +1 (646) 9806461

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

res

INGREDIENTS AND APPEARANCE

SPOTLIGHT MOUTHWASH FOR WHITENING TEETH 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75065-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CARRAGEENAN (UNII: 5C69YCD2YJ)
PSEUDOMONAS GLUCOSE FERMENTATION RHAMNOLIPIDS (UNII: PB22NX2CJL)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color		Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75065-001-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/01/2020	12/31/2023

Labeler - Oral Spotlight Care Inc (117405870)

Registrant - Oral Spotlight Care Inc (117405870)