HOO GARGLE (MOUTHWASH)- xylitol liquid 
MIKO CO LTD

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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) 
xylitol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81840-1001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) XYLITOL1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81840-1001-3100 in 1 PACKAGE04/20/2021
1NDC:81840-1001-230 in 1 PACKAGE
1NDC:81840-1001-110 mL in 1 CUP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/20/2021
Labeler - MIKO CO LTD (689973854)
Registrant - MIKO CO LTD (689973854)
Establishment
NameAddressID/FEIBusiness Operations
MIKO CO LTD689973854manufacture(81840-1001)

Revised: 6/2022
Document Id: e22b8f86-7412-6e61-e053-2995a90ae0ea
Set id: e22b8f0a-0321-b7f1-e053-2995a90a1d35
Version: 1
Effective Time: 20220624
 
MIKO CO LTD