HOO GARGLE APPLE SPEARMINT FLAVOR- sodium fluoride liquid

Hoo Gargle Apple Spearmint Flavor by

Drug Labeling and Warnings

Hoo Gargle Apple Spearmint Flavor by is a Otc medication manufactured, distributed, or labeled by Nuriearth Global Co., Ltd., Miko Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Hoo Gargle Apple Spearmint Flavor Active Ingredient

Sodium Flouride 0.02%

Hoo Gargle Apple Spearmint Flavor Ask Doctor

Children under 6 years of age: consult a dentist or doctor

Hoo Gargle Apple Spearmint Flavor Warning

Warnings

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Hoo Gargle Apple Spearmint Flavor Keep Out of Reach of Children

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Hoo Gargle Apple Spearmint Flavor Questions

Questions/Comments:

Call +1-203-908-5154

Hoo Gargle Apple Spearmint Flavor Directions

Directions

adults and children 6 years of age and older:

use before or after brushing your teeth with a toothpaste or use whenever you want but do not use more than 3 times a day
vigorously swish 10mililiters (2 teaspoonfuls) of rinse between your teeth for 1 minutes and then spit out
do not swallow the rinse
do not eat or drink for 30 minutes after rinsing
instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
supervise children as necessary until capable of using without supervision

Hoo Gargle Apple Spearmint Flavor Inactive Ingredient

water, L-menthol, xylitol, sodium acetate, alanine, acetic acid, propolis, chitosan, green tea extract. stevia, cyclodextrin. benzoic acid. red ginsengs extract, caramel. grapefruit seed extract, maple flavor, apple spearmint flavor

Hoo Gargle Apple Spearmint Flavor Indications

aids in the prevention of dental cavities

Hoo Gargle Apple Spearmint Flavor Purpose

anticavity

Hoo Gargle Apple Spearmint Flavor Package Label

INGREDIENTS AND APPEARANCE

HOO GARGLE APPLE SPEARMINT FLAVOR 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83367-100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)	10 mg  in 1 mL
ALANINE (UNII: OF5P57N2ZX)	0.5 mg  in 1 mL
(2-AMINO-5,6-DICHLOROQUINAZOLIN-3(4H )-YL)ACETIC ACID (UNII: 03TUA9L576)	0.5 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A)	0.6 mg  in 1 mL
SODIUM ACETATE (UNII: 4550K0SC9B)	0.5 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83367-100-02	1 in 1 PACKAGE	04/01/2023
1	NDC: 83367-100-01	15 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 83367-100-04	1 in 1 PACKAGE	04/01/2023
2	NDC: 83367-100-03	30 mL in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 83367-100-06	1 in 1 PACKAGE	04/01/2023
3	NDC: 83367-100-05	50 mL in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 83367-100-08	1 in 1 PACKAGE	04/01/2023
4	NDC: 83367-100-07	100 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M022	04/01/2023

Labeler - Nuriearth Global Co., Ltd. (695456265)

Registrant - Nuriearth Global Co., Ltd. (695456265)

Establishment
Name	Address	ID/FEI	Business Operations
Miko Co Ltd		695188803	manufacture(83367-100)