X-PUR OPTI-RINSE PLUS- anticavity fluoride rinse mouthwash

X-Pur Opti-Rinse Plus by

Drug Labeling and Warnings

X-Pur Opti-Rinse Plus by is a Otc medication manufactured, distributed, or labeled by Oral Science Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)............Anticavity

Purpose

Anticavity

Use

aids in the prevention of dental cavities.

Warnings

Keep out of the reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Stop use and ask a doctor or dentist if symptoms persist or condition worsens after regular use

STOP USE

Stop use and ask a doctor or dentist if symptoms persist or condition worsens after regular use

KEEP OUT OF REACH OF CHILDREN

If more than used for rinsing is accidently swallowed, get medical help or contact a Poison Control Center right away

Directions

• Adults and children 6 years and older:

Use once a day after brushing your teeth with a toothpaste
Remove cap
Pour 10 milliliters into a cap (10 mL mark on the inside of cap); do not fill above 10 mL mark Vigorously swish 10 milliliters 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 brushing and rinsing habits (to minimize swallowing)
Supervise children as necessary until capable of using without supervision

• Children 6 years and under

Consult a dentist or doctor

Inactive ingredients

water, xylitol, glycerin, poloxamer 407, grape flavor, sodium phosphate, bioflavonoids, benzoic acid, cetylpyridinium chloride, mint flavor, red 40

OTHER SAFETY INFORMATION

store at room temperature (59-86°F) do not use if safety seal is broken or missing

Package Label - Principal Display Panel

500 mL NDC: 81359-112-11

INGREDIENTS AND APPEARANCE

X-PUR OPTI-RINSE PLUS 
anticavity fluoride rinse mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81359-112
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
BENZOIC ACID (UNII: 8SKN0B0MIM)
XYLITOL (UNII: VCQ006KQ1E)
POLOXAMER 407 (UNII: TUF2IVW3M2)
GRAPE (UNII: 6X543N684K)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
MINT (UNII: FV98Z8GITP)
GLYCERIN (UNII: PDC6A3C0OX)
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE (UNII: SE337SVY37)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81359-112-11	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/04/2021

Labeler - Oral Science Inc (200633202)