DR.PIK ORAL CARE GARGLE- sodium fluoride liquid

Dr.pik Oral Care Gargle by

Drug Labeling and Warnings

Dr.pik Oral Care Gargle by is a Otc medication manufactured, distributed, or labeled by Dr.pik Co.,ltd, Ecoworld Co .,ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Sodium fluoride 0.05%

INACTIVE INGREDIENT

Inactive ingredients:
Water, Alcohol, Xyitol, Flavor (apple spearmint), L-Menthol, Acetic acid, Sodium benzoate, Sodium citrate, Citric acid, Stevioside, Sodium saccharin

PURPOSE

Purpose: Anticaries

WARNINGS

Warnings:
1) Keep the prescribed usage, capacity. 2) When using to children, please use under the guidance and supervision of the guardian. 3) Since this product is high in concentration, be sure to add it to the water supply tank of the Dr.pik’s 'Vacuum Oral Care'. 4) Use only for oral cleaning. Do not use besides the intended use. If large quantities have been swallowed, consult a physician immediately. 5) Children under 6 years old, please do not use without instructions from a pharmacist or doctor. 6) Please keep out of reach of children. 7) Avoid direct sunlight, keep as cool as possible. 8) Please do not put in another container for quality preservation.

KEEP OUT OF REACH OF CHILDREN

Please keep out of reach of children.

Uses

Uses:
Helps prevent dental caries and remove bad breath.

Directions

Directions:
Add 15ml of Dr.pik Oral Care Gargle measured by the cap to the supply tank of Vacuum Oral Care.
After filling water up to the line of the supply tank, add Dr.pik Oral Care Gargle.
Do not use the solution without diluting for gargling purpose.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.PIK ORAL CARE GARGLE 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72857-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 300 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72857-010-01	300 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/02/2019

Labeler - Dr.pik Co.,ltd (694609614)

Registrant - Dr.pik Co.,ltd (694609614)

Establishment
Name	Address	ID/FEI	Business Operations
Ecoworld Co .,ltd		688735061	manufacture(72857-010)