HOO GARGLE (APPLE SPEARMINT FLAVOR)- 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 (APPLE SPEARMINT FLAVOR) 
sodium flouride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81840-3333
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.02 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81840-3333-5100 in 1 PACKAGE09/20/2022
1NDC:81840-3333-450 in 1 PACKAGE
1NDC:81840-3333-330 in 1 PACKAGE
1NDC:81840-3333-215 in 1 PACKAGE
1NDC:81840-3333-110 in 1 PACKAGE
1NDC:81840-3333-010 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/20/2022
Labeler - MIKO CO LTD (689973854)
Registrant - MIKO CO LTD (689973854)
Establishment
NameAddressID/FEIBusiness Operations
MIKO CO LTD689973854manufacture(81840-3333)

Revised: 9/2022
Document Id: e914892c-249b-9587-e053-2a95a90a88ed
Set id: e9148945-57e6-2bba-e053-2995a90a8af3
Version: 1
Effective Time: 20220919
 
MIKO CO LTD