Spotlight​ ​® Oral Care Anticavity Mouthwash for Gum Health

Mouthwash for Gum Health by

Drug Labeling and Warnings

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

Drug Details [pdf]

MOUTHWASH FOR GUM HEALTH- sodium fluoride liquid 
Oral Spotlight Care Inc

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Spotlight​​® Oral Care Anticavity Mouthwash for Gum Health

Drug Facts

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

Purpose  Anticavity

Use  aids in the prevention of dental cavities.

Warnings

Keep out of reach of children.

If more than used is accidentally swallowed, get

medical help or contact a Poison Control Center right away.

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 information  Store at room temperature.

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

Questions?  +1 (646) 9806461

Product Label

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

res

MOUTHWASH FOR GUM HEALTH 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75065-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PSEUDOMONAS GLUCOSE FERMENTATION RHAMNOLIPIDS (UNII: PB22NX2CJL)
PEPPERMINT OIL (UNII: AV092KU4JH)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SAFFLOWER (UNII: 4VBL71TY4Y)
ALLANTOIN (UNII: 344S277G0Z)
BETA VULGARIS (UNII: 4G174V5051)
SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75065-002-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M023	05/01/2021	12/31/2023

Labeler - Oral Spotlight Care Inc (117405870)

Registrant - Oral Spotlight Care Inc (117405870)

Revised: 11/2023

Document Id: b7d9ebe5-beef-4753-97ba-082c95998766

34390-5

Set id: 04fab543-e6dd-4f34-9f22-e39e86abb6bd

Version: 3

Effective Time: 20231119