Spotlight​ ​® Oral Care Anticavity Mouthwash for Total Care

Mouthwash for Total Care by

Drug Labeling and Warnings

Mouthwash for Total Care 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 TOTAL CARE- 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 Anticavity Mouthwash for Total Care

Drug Facts

Sodium Fluoride 0.045% (.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 Water, Glycerin, Xylitol, Xanthan Gum, Mentha
Arvensis (peppermint) Oil, Sodium Benzoate, Sodium
Saccharin, Monosodium Phosphate, Phosphoric Acid.

Questions?  +1 (646) 9806461

Product Label

Spotlight®

Oral Care

CREATED BY DENTISTS

       T

Mouthwash
for Total Care

Aids in Cavity Protection,
& Remineralization

-- 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 TOTAL CARE 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75065-003
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)
XANTHAN GUM (UNII: TTV12P4NEE)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
PHOSPHORIC ACID (UNII: E4GA8884NN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75065-003-01	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 final	part355	05/01/2021	12/31/2023

Labeler - Oral Spotlight Care Inc (117405870)

Registrant - Oral Spotlight Care Inc (117405870)

Revised: 1/2023

Document Id: 199b3979-d6ab-42ea-bdfe-ceda955af783

34390-5

Set id: 12bfd758-ec50-408d-a470-45a23ba396e4

Version: 2

Effective Time: 20230118