OTC Medication Information: Hoo Gargle (Jasmine Flavor)(Mouthwash)

HOO GARGLE (JASMINE FLAVOR)(MOUTHWASH)- sodium fluoride 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.

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:81840-1111 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 0.02 g in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:81840-1111-5 100 PACKAGE in 1 PACKAGE contains a PACKAGE (81840-1111-4) 1 NDC:81840-1111-4 50 PACKAGE in 1 PACKAGE This package is contained within the PACKAGE (81840-1111-5) and contains a PACKAGE (81840-1111-3) 1 NDC:81840-1111-3 30 PACKAGE in 1 PACKAGE This package is contained within the PACKAGE (81840-1111-4) and contains a PACKAGE (81840-1111-2) 1 NDC:81840-1111-2 15 PACKAGE in 1 PACKAGE This package is contained within the PACKAGE (81840-1111-3) and contains a PACKAGE (81840-1111-1) 1 NDC:81840-1111-1 10 POUCH in 1 PACKAGE This package is contained within the PACKAGE (81840-1111-2) and contains a POUCH (81840-1111-0) 1 NDC:81840-1111-0 10 mL in 1 POUCH This package is contained within a PACKAGE (81840-1111-1) and a PACKAGE (81840-1111-2) and a PACKAGE (81840-1111-3) and a PACKAGE (81840-1111-4) and a PACKAGE (81840-1111-5)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/02/2021

Labeler — MIKO CO LTD (689973854)

Registrant — MIKO CO LTD (689973854)

Establishment
Name	Address	ID/FEI	Operations
MIKO CO LTD		689973854	manufacture (81840-1111)

Revised: 10/2022 MIKO CO LTD