Dr.NOAH MARUFTOOTHPASTE by SUNGWON PHARMACEUTICAL CO., LTD. / DONG IL PHARMS CO., LTD.

Dr.NOAH MARUFTOOTHPASTE by

Drug Labeling and Warnings

Dr.NOAH MARUFTOOTHPASTE by is a Otc medication manufactured, distributed, or labeled by SUNGWON PHARMACEUTICAL CO., LTD., DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DR.NOAH MARUFTOOTHPASTE- sodium monofluorophosphate paste 
SUNGWON PHARMACEUTICAL CO., 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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ACTIVE INGREDIENT

Sodium Fluoride

INACTIVE INGREDIENT

Precipitated Calcium Carbonate
Xanthangum
Sodium Chloride
Steviol Glycoside
Xylitol
D-Sorbitol Solution
Concentrated Glycerin
Sodium Cocoyl Glutamate
Sodium Cocoyl Isethionate
Bioactive Herb Complex-C
L-Menthol
Menthol Pulegium Oil
Peppermint Oil
Spearmint Oil
Sage Extract
Aloe Extract
Green Tea Extract
Water

PURPOSE

■ Keeps teeth white and strong

■ Keep the oral cavity clean

■ Prevents tooth decay and bad breath caused by fluoride

■ Removing plaque, preventing gingivitis and periodontitis

■ Periodontal Disease Prevention

■ Gum Disease Prevention

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

WARNING

For oral use only
When using this product

■ This toothpaste has a 1,000 ppm fluoride content

■ Do not use other than brushing teeth and be careful not to swallow

Keep out of reach of children

■ if swallowed, seek medical help or contact the poison control center immediately

USES

for oral use only

INDICATION & USAGE SECTION

Brush thoroughly ofter each meal or at least twice a day, as directed by yourdoctorordendst
Do not swallow.

Do not use if seal is broken or missing.

store in a cool, dry place.

DR.NOAH MARUFTOOTHPASTE 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76058-005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76058-005-01	120 g in 1 TUBE; Type 0: Not a Combination Product	09/17/2021	12/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/17/2021	12/01/2021

Labeler - SUNGWON PHARMACEUTICAL CO., LTD. (689787898)

Registrant - SUNGWON PHARMACEUTICAL CO., LTD. (689787898)

Establishment
Name	Address	ID/FEI	Business Operations
SUNGWON PHARMACEUTICAL CO., LTD.		689787898	manufacture(76058-005)

Revised: 12/2021

Document Id: d27180f0-7eb8-8eb8-e053-2a95a90ac7c1

34390-5

Set id: cc29376c-5198-a54b-e053-2995a90a25e3

Version: 3

Effective Time: 20211205