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Glowing White by Onpoint, Inc

Medically reviewed on August 7, 2017

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.2mg in 1mL
Labeler: Onpoint, Inc
NDC Code: 51143-435

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.

Whitening Anticavity Mouth Rinse

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

for this product

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 6 years of age and older:

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (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

Inactive ingredients

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Other information

store at room temperature (59º-77ºF)

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine HealthyWhite Vibrant Anticavity Mouthrinse

Contains peroxide which releases oxygen while whitening.  This may cause the bottle to inflate slightly or release air when opened

claims

Live Better products provide a simple way to look after yourself and your family.  All of our products are crafted from high quality ingredents exacting standards.

Live Better is a great way to meet the health needs of our busy lifestyle.  Live Better helps you be better

Live Better, for life.

Adverse Reactions

DISTRIBUTED BY ONPOINT, INC.

2 PARAGON DRIVE

MONTVALE, NJ 07465

Principal Display Panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Live Better

Glowing

White

Anticavity Mouthwash

FRESH MINT

Compare to Listerine HealthyWhite

Vibrant Anticavity Mouthrinse

  • 5 DAYS TO WHITER TEETH
  • BEGINS WORKING ON CONTACT
  • HELPS STRENGTHEN TEETH
  • KILLS GERMS THAT CAUSE BAD BREATH

IMPORTANT:read directions for proper use.

32 FL OZ (946 mL)

GLOWING WHITE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51143-435
Route of AdministrationoralDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
HYDROGEN PEROXIDE 
POLOXAMER 407 
SACCHARIN SODIUM 
SUCRALOSE 
MENTHOL 
PHOSPHORIC ACID 
SODIUM PHOSPHATE, DIBASIC ANHYDROUS 
Packaging
#Item CodePackage Description
1NDC:51143-435-45946 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/29/2015
Labeler - Onpoint, Inc (001367366)
Establishment
NameAddressID/FEIOperations
Vi-Jon, Inc.790752542manufacture(51143-435)

 
Onpoint, Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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