HOO GARGLE (ROOIBOS TEA FLAVOR)(MOUTHWASH)- sodium flouride liquid

Hoo gargle (Rooibos Tea Flavor)(Mouthwash) by

Drug Labeling and Warnings

Hoo gargle (Rooibos Tea Flavor)(Mouthwash) by is a Otc medication manufactured, distributed, or labeled by MIKO CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

sodium fluoride

INACTIVE INGREDIENT

menthol

xylitol

Sodium acetate

Allanine
Acetic acid
Propolis
Chitosan
Green tea extract

Stevia
Cyclodextrin
Benzoic acid
Red ginsengs extract

Caramel
Grapefruit seed extract

Maple flavor
Rooibos tea flavor

Purified Water

PURPOSE

dental care

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE

1. Put one cup in mouth.

2. Gargle for 30 sec ~ 1 minute

3. Spit it out.

5. Rinse with water.

WARNINGS

Be careful not to swallow it, and rinse your mouth thoroughly after use.

DOSAGE & ADMINISTRATION

dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HOO GARGLE (ROOIBOS TEA FLAVOR)(MOUTHWASH) 
sodium flouride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81840-2222
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81840-2222-5	100 in 1 PACKAGE	09/20/2022
1	NDC: 81840-2222-4	50 in 1 PACKAGE
1	NDC: 81840-2222-3	30 in 1 PACKAGE
1	NDC: 81840-2222-2	15 in 1 PACKAGE
1	NDC: 81840-2222-1	10 in 1 PACKAGE
1	NDC: 81840-2222-0	10 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	07/03/2022

Labeler - MIKO CO LTD (689973854)

Registrant - MIKO CO LTD (689973854)

Establishment
Name	Address	ID/FEI	Business Operations
MIKO CO LTD		689973854	manufacture(81840-2222)