Hoo Gargle (Jasmine Flavor)(Mouthwash): Package Insert and Label Information

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

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:81840-0002
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:81840-0002-3 64 PACKAGE in 1 PACKAGE contains a PACKAGE (81840-0002-2)
1 NDC:81840-0002-2 30 CUP in 1 PACKAGE This package is contained within the PACKAGE (81840-0002-3) and contains a CUP (81840-0002-1)
1 NDC:81840-0002-1 12 mL in 1 CUP This package is contained within a PACKAGE (81840-0002-2) and a PACKAGE (81840-0002-3)
2 NDC:81840-0002-6 64 PACKAGE in 1 PACKAGE contains a PACKAGE (81840-0002-5)
2 NDC:81840-0002-5 8 CUP in 1 PACKAGE This package is contained within the PACKAGE (81840-0002-6) and contains a CUP (81840-0002-4)
2 NDC:81840-0002-4 10 mL in 1 CUP This package is contained within a PACKAGE (81840-0002-5) and a PACKAGE (81840-0002-6)
3 NDC:81840-0002-9 40 PACKAGE in 1 PACKAGE contains a PACKAGE (81840-0002-8)
3 NDC:81840-0002-8 20 POUCH in 1 PACKAGE This package is contained within the PACKAGE (81840-0002-9) and contains a POUCH (81840-0002-7)
3 NDC:81840-0002-7 10 mL in 1 POUCH This package is contained within a PACKAGE (81840-0002-8) and a PACKAGE (81840-0002-9)
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 (81840-0002)

Revised: 08/2022 MIKO CO LTD

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