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White Glo 2in1 with Mouthwash by Barros Laboratories Pty Limited

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 7.6mg in 1g
Labeler: Barros Laboratories Pty Limited
NDC Code: 68368-155

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.

White Glo 2in1 with Mouthwash

DRUG FACTS

Active Ingredient

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity toothpaste

Use

helps protect against cavities

Warnings

Keep out of reach of children

under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • adults and children 2 years & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
  • do not swallow
  • to minimize swalowing use a pea-sized amount in children under 6 
  • supervise children's brushing until good habits are established 
  • children under 2 years ask a dentist.

Inactive ingredients

Calcium Carbonate, Aqua (water), Glycerin, Sorbitol, Silica, Denature Alcohol (2.5%), Aroma (Flavor), Sodium Lauryl Sulfate, Carboxymethyl Hydroxylcellulose, Chondrus Crispus (Carrageenan), CI 77891 (Titanium Dioxide), Sodium Saccharin, Rosa Canina Fruit Oil.

Questions or comments?

questions@white-glo.net

Package Labeling:

WHITE GLO 2IN1 WITH MOUTHWASH 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68368-155
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
WATER 
GLYCERIN 
SORBITOL 
SILICON DIOXIDE 
METHYL SALICYLATE 
SODIUM LAURYL SULFATE 
CARRAGEENAN 
TITANIUM DIOXIDE 
SACCHARIN SODIUM 
ROSA CANINA FRUIT OIL 
Packaging
#Item CodePackage Description
1NDC:68368-155-033 g in 1 TUBE
2NDC:68368-155-055 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/2018
Labeler - Barros Laboratories Pty Limited (751813452)

Revised: 12/2017
 
Barros Laboratories Pty Limited

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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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