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Ora 2 stain clear by Sunstar Guangzhou Ltd.

Medically reviewed on August 24, 2017

Dosage form: paste
Ingredients: SODIUM FLUORIDE 0.1g in 100g
Labeler: Sunstar Guangzhou Ltd.
NDC Code: 53050-001

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.

TOOTHPASTE DRUG FACTS

Active Ingredient

Sodium Fluoride 0.1%

Purpose

Anticavity toothpaste

Use

aids in the prevention of dental decay

Warning

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 and older

Brush teeth thoroughly after meals or at least twice a day,or use as directed by a dentise or physician

children under 6 years

Instruct in good brushing and rinsing habits (to minimize swallowing)

children under 2 years

Ask a dentist or physician

Inactive Ingredients

Water, Silica, Sorbital, Glycerin, PEG-8, Sodium Lauryl Sulfate, Disodium C12-14 Pareth-2 Sulfosuccinate,Flavor, Xanthan Gum,,PEG-60 Hydrogenated Castor Oil, Titanium Dioxide, Cellulose Gum, Sodium Fluoride,Sodium Saccharin, Algin, Stevia Rebaudiana Extract, O-Cymen-5-Ol

Keep out of reach of children under 6 years of ageKeep out of reach of children under 6 years of age

ORA 2 STAIN CLEAR 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53050-001
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (Fluoride Ion) SODIUM FLUORIDE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol 
SILICON DIOXIDE 
POLYETHYLENE GLYCOL 400 
GLYCERIN 
SODIUM LAURYL SULFATE 
WATER 
XANTHAN GUM 
POLYOXYL 60 HYDROGENATED CASTOR OIL 
DISODIUM C12-14 SEC-PARETH-12 SULFOSUCCINATE 
TITANIUM DIOXIDE 
CELLULOSE ACETATE 
SODIUM SARCOSINATE 
ALGINIC ACID 
STEVIA REBAUDIUNA LEAF 
O-CYMEN-5-OL 
Packaging
#Item CodePackage Description
1NDC:53050-001-0125 g in 1 TUBE
2NDC:53050-001-0240 g in 1 TUBE
3NDC:53050-001-035 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/22/2012
Labeler - Sunstar Guangzhou Ltd. (544725724)
Establishment
NameAddressID/FEIOperations
Sunstar Guangzhou Ltd.544725724manufacture(53050-001)

 
Sunstar Guangzhou Ltd.

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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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