Do Clear by Sunstar Guangzhou Ltd. 53050-003 Do Clear

Do Clear by

Drug Labeling and Warnings

Do Clear by is a Otc medication manufactured, distributed, or labeled by Sunstar Guangzhou Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DO 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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53050-003 Do Clear

Active Ingredient

Sodium Fluoride 0.05%

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

SILICON DIOXIDE,ISOMALT,CARBOXYMETHYLCELLULOSE SODIUM,WATER,SACCHARIN SODIUM,SODIUM PHOSPHATE,TITANIUM DIOXIDE,SORBITOL,METHYLPARABEN

Keep out of reach of children under 6 years of age

Keep out of reach of children under 6 years of age

DO CLEAR 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53050-003
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.11 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISOMALT (UNII: S870P55O2W)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PHOSPHATE (UNII: SE337SVY37)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53050-003-01	1000 in 1 CARTON	08/01/2018	02/28/2020
1		5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/22/2012	02/28/2020

Labeler - Sunstar Guangzhou Ltd. (544725724)

Establishment
Name	Address	ID/FEI	Business Operations
Sunstar Guangzhou Ltd.		544725724	manufacture(53050-003)

Revised: 2/2020

Document Id: 9fa4887f-7c16-1461-e053-2995a90a9e11

34390-5

Set id: 71c9641f-2635-c207-e053-2995a90a23e6

Version: 3

Effective Time: 20200228

 

Sunstar Guangzhou Ltd.