Hoo gargle (Jasmine Flavor)(Mouthwash) by MIKO CO LTD Drug Facts

Hoo gargle (Jasmine Flavor)(Mouthwash) by

Drug Labeling and Warnings

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

Drug Details [pdf]

HOO GARGLE (JASMINE FLAVOR)(MOUTHWASH)- sodium flouride liquid 
MIKO 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.

----------

Drug Facts

sodium fluoride

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

Jasmine flavor

Purified Water

dental care

KEEP OUT OF REACH OF THE CHILDREN

1. Put one cup in mouth.

2. Gargle for 30 sec ~ 1 minute

3. Spit it out.

5. Rinse with water.

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

dental use only

HOO GARGLE (JASMINE FLAVOR)(MOUTHWASH) 
sodium flouride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81840-0002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.02 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: 81840-0002-3	64 in 1 PACKAGE	02/02/2021	09/19/2023
1	NDC: 81840-0002-2	30 in 1 PACKAGE
1	NDC: 81840-0002-1	12 mL in 1 CUP; Type 0: Not a Combination Product
2	NDC: 81840-0002-6	64 in 1 PACKAGE	08/02/2022	09/20/2023
2	NDC: 81840-0002-5	8 in 1 PACKAGE
2	NDC: 81840-0002-4	10 mL in 1 CUP; Type 0: Not a Combination Product
3	NDC: 81840-0002-9	40 in 1 PACKAGE	08/06/2022	09/20/2023
3	NDC: 81840-0002-8	20 in 1 PACKAGE
3	NDC: 81840-0002-7	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 final	part355	02/02/2021	09/20/2023

Labeler - MIKO CO LTD (689973854)

Registrant - MIKO CO LTD (689973854)

Establishment
Name	Address	ID/FEI	Business Operations
MIKO CO LTD		689973854	manufacture(81840-0002)

Revised: 9/2023

Document Id: 05c33d78-02c6-2a88-e063-6394a90af917

34390-5

Set id: c84042bd-d42b-214a-e053-2995a90a5049

Version: 8

Effective Time: 20230920