53050-011Ora 2 stain clear

Ora 2 stain clear by

Drug Labeling and Warnings

Ora 2 stain clear by is a Otc medication manufactured, distributed, or labeled by Sunstar Guangzhou Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ORA 2 STAIN CLEAR- sodium fluoride paste 
Sunstar Guangzhou Ltd.

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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53050-011Ora 2 stain clear

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 age

Keep out of reach of children under 6 years of age

ORA 2 STAIN CLEAR 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53050-011
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
DISODIUM C12-14 SEC-PARETH-12 SULFOSUCCINATE (UNII: 10Y54T6DXH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
SODIUM SARCOSINATE (UNII: 6EHN3PQL8Z)
ALGINIC ACID (UNII: 8C3Z4148WZ)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53050-011-01	25 g in 1 TUBE; Type 0: Not a Combination Product	04/05/2017	03/06/2020
2	NDC: 53050-011-02	40 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2017	03/06/2020
3	NDC: 53050-011-03	5 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2017	03/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/22/2012	03/06/2020

Labeler - Sunstar Guangzhou Ltd. (544725724)

Establishment
Name	Address	ID/FEI	Business Operations
Sunstar Guangzhou Ltd.		544725724	manufacture(53050-011)

Revised: 3/2020

Document Id: a031c9bf-10d4-23e4-e053-2995a90a061f

34390-5

Set id: 68e9f68c-5347-389e-e053-2a91aa0ae773

Version: 3

Effective Time: 20200306