Spotlight Oral Care Mouthwash for Whitening Teeth

Drug Details [pdf]

SPOTLIGHT MOUTHWASH FOR WHITENING TEETH- sodium fluoride liquid
Oral Spotlight Care Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Spotlight Oral Care Mouthwash for Whitening Teeth

Drug Facts

Active ingredient Sodium Fluoride 0.05%

Purpose Anticavity

Use aids in the prevention of dental cavities

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. If more than used for rinsing

is accidentally swallowed, get medical help or contact a

Poison Control Center right away.

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 information ■ store at room temperature

Inactive Ingredients

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

Sodium Saccharin, Carrageenen, Glycolipids, Mentha

Piperita (peppermint) oil , Sodium Benzoate

Questions? +1 (646) 9806461

Spotlight

Oral Care

CREATED BY DENTISTS

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 MWash

res

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - Oral Spotlight Care Inc (117405870)

Registrant - Oral Spotlight Care Inc (117405870)

Revised: 1/2023

Document Id: dc196a56-98a8-4125-966b-2c6c84011f52

Set id: 64328e9f-ede7-42c5-a604-2983ffcd6918

Version: 2

Effective Time: 20230118

Spotlight Oral Care Mouthwash for Whitening Teeth

Spotlight Mouthwash for Whitening Teeth by

Drug Labeling and Warnings

Drug Details [pdf]

Spotlight Oral Care Mouthwash for Whitening Teeth