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NDC 76058-0500-01 ORAL PROJEQT O1 TOOTHPASTETABLETS .05; 5; .22; 1 g/1; g/1; g/1; g/1 Details

ORAL PROJEQT O1 TOOTHPASTETABLETS .05; 5; .22; 1 g/1; g/1; g/1; g/1

ORAL PROJEQT O1 TOOTHPASTETABLETS is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Sungwon Pharmaceutical Co., Ltd.. The primary component is PYRIDOXINE HYDROCHLORIDE; SILICON DIOXIDE; SODIUM FLUORIDE; SODIUM PYROPHOSPHATE.

Product Information

NDC	76058-0500
Product ID	76058-500_e6de7e90-4789-18dc-e053-2995a90a63d5
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ORAL PROJEQT O1 TOOTHPASTETABLETS
Proprietary Name Suffix	n/a
Non-Proprietary Name	sodium fluoride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	.05; 5; .22; 1
Active Ingredient Units	g/1; g/1; g/1; g/1
Substance Name	PYRIDOXINE HYDROCHLORIDE; SILICON DIOXIDE; SODIUM FLUORIDE; SODIUM PYROPHOSPHATE
Labeler Name	Sungwon Pharmaceutical Co., Ltd.
Pharmaceutical Class	Analogs/Derivatives [Chemical/Ingredient], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 76058-0500-01 (76058050001)

Pricing Information	N/A
NDC Package Code	76058-500-01
Billing NDC	76058050001
Package	62 TABLET in 1 BOTTLE, GLASS (76058-500-01)
Marketing Start Date	2022-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e6de7e8a-08c8-962f-e053-2995a90aee46 Details

ACTIVE INGREDIENT

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

INACTIVE INGREDIENT

D-Sorbitol, Microcrystalline Cellulose, Sodium Chloride, Xylitol, Enzymatically Modified Stevia, Sodium Cocoyl Glutamate, GreenTea Flavor Powder, Combined Flavor(Coolmint Flavor Powder), Combined Flavor(Peppermint Flavor Powder), L-Menthol, Lemon Juice, Aloe Extract Powder, Tea Extract, Hydroxyapatite, Xanthan Gum, Hydroxypropylcellulose, Sodium Bicarbonate, Magnesium Stearate

PURPOSE

Helps protect against cavities and freshen breath.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

WARNING

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 immediately.

This toothpaste contains 1000ppm of fluorine.

If children under 6 years of age swallowed an over dose, get

medical help or contact a Poison Control Center immediately.

USES

for oral use only

INDICATION & USAGE SECTION

Adults and children 6 years of age and older

Literally chew a tablet then brush teeeth thoroughly,

preferably after each meal or at least twice a day, every day,

or as directed by a dentist or physician.

DO NOT swallow a tablet.

Children under 6 years of age: Consult a dentist or doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORAL PROJEQT O1 TOOTHPASTETABLETS

sodium fluoride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76058-500
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.22 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	5 g
SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ)	SODIUM PYROPHOSPHATE	1 g
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	0.05 g

Ingredient Name	Strength
Inactive Ingredients
XYLITOL (UNII: VCQ006KQ1E)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	None
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76058-500-01	62 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	08/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		08/01/2022

Labeler - Sungwon Pharmaceutical Co., Ltd. (689787898)

Registrant - Sungwon Pharmaceutical Co., Ltd. (689787898)

Name	Address	ID/FEI	Business Operations
Establishment
Sungwon Pharmaceutical Co., Ltd.		689787898	manufacture(76058-500)

Revised: 8/2022

Document Id: e6de7e90-4789-18dc-e053-2995a90a63d5

Set id: e6de7e8a-08c8-962f-e053-2995a90aee46

Version: 1

Effective Time: 20220822