Hoo gargle (Mouthwash) by MIKO CO LTD Drug Facts

Drug Details [pdf]

HOO GARGLE (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.

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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
Apple spearmint 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

label

HOO GARGLE (MOUTHWASH)
sodium flouride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81840-0001
Route of Administration	DENTAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 81840-0001-3	100 in 1 PACKAGE	07/03/2022	09/20/2023
1	NDC: 81840-0001-2	30 in 1 PACKAGE
1	NDC: 81840-0001-1	10 mL in 1 CUP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	04/20/2021	09/20/2023

Labeler - MIKO CO LTD (689973854)

Registrant - MIKO CO LTD (689973854)

Name	Address	ID/FEI	Business Operations
Establishment
MIKO CO LTD		689973854	manufacture(81840-0001)

Revised: 9/2023

Document Id: 05c374f3-e95d-e367-e063-6294a90a2d9a

Set id: c06317be-29be-fefd-e053-2995a90a3fc6

Version: 5

Effective Time: 20230920