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

HOO GARGLE (JASMINE FLAVOR)(MOUTHWASH)- sodium fluoride liquid
MIKO CO LTD

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

label
(click image for full-size original)

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 Drug M021 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: 10/2023 MIKO CO LTD

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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