HOO GARGLE APPLE SPEARMINT FLAVOR- sodium fluoride liquid 
Nuriearth Global 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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Hoo Gargle Apple Spearmint Flavor Active Ingredient

Sodium Flouride 0.02%

Hoo Gargle Apple Spearmint Flavor Ask Doctor

Children under 6 years of age: consult a dentist or doctor

Hoo Gargle Apple Spearmint Flavor Warning

Warnings

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Hoo Gargle Apple Spearmint Flavor Keep Out of Reach of Children

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Hoo Gargle Apple Spearmint Flavor Questions

Questions/Comments:

Call +1-203-508-5154

Hoo Gargle Apple Spearmint Flavor Directions

Directions

adults and children 6 years of age and older:

use before or after brushing your teeth with a toothpaste or use whenever you want but do not use more than 3 times a day
vigorously swish 10mililiters (2 teaspoonfuls) of rinse between your teeth for 1 minutes and then spit out
do not swallow the rinse
do not eat or drink for 30 minutes after rinsing
instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
supervise children as necessary until capable of using without supervision

Hoo Gargle Apple Spearmint Flavor Inactive Ingredient

water, L-menthol, xylitol, sodium acetate, alanine, acetic acid, propolis, chitosan, green tea extract. stevia, cyclodextrin. benzoic acid. red ginsengs extract, caramel. grapefruit seed extract, maple flavor, apple spearmint flavor

Hoo Gargle Apple Spearmint Flavor Indications

aids in the prevention of dental cavities

Hoo Gargle Apple Spearmint Flavor Purpose

anticavity

Hoo Gargle Apple Spearmint Flavor Package Label

Hoo Gargle Apple Spearmint Flavor 15 packetsHoo Gargle Apple Spearmint Flavor 30 packetsHoo Gargle Apple Spearmint Flavor 50 packetsHoo Gargle Apple Spearmint Flavor 100 packets

HOO GARGLE APPLE SPEARMINT FLAVOR 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83367-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E) 10 mg  in 1 mL
ALANINE (UNII: OF5P57N2ZX) 0.5 mg  in 1 mL
(2-AMINO-5,6-DICHLOROQUINAZOLIN-3(4H )-YL)ACETIC ACID (UNII: 03TUA9L576) 0.5 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) 0.6 mg  in 1 mL
SODIUM ACETATE (UNII: 4550K0SC9B) 0.5 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83367-100-021 in 1 PACKAGE04/01/2023
1NDC:83367-100-0115 mL in 1 PACKET; Type 0: Not a Combination Product
2NDC:83367-100-041 in 1 PACKAGE04/01/2023
2NDC:83367-100-0330 mL in 1 PACKET; Type 0: Not a Combination Product
3NDC:83367-100-061 in 1 PACKAGE04/01/2023
3NDC:83367-100-0550 mL in 1 PACKET; Type 0: Not a Combination Product
4NDC:83367-100-081 in 1 PACKAGE04/01/2023
4NDC:83367-100-07100 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02204/01/2023
Labeler - Nuriearth Global Co., Ltd. (695456265)
Registrant - Nuriearth Global Co., Ltd. (695456265)
Establishment
NameAddressID/FEIBusiness Operations
Miko Co Ltd695188803manufacture(83367-100)

Revised: 3/2023
Document Id: f7e6ec5a-f21c-eced-e053-6294a90a6309
Set id: f7e6ec5a-f21b-eced-e053-6294a90a6309
Version: 1
Effective Time: 20230327
 
Nuriearth Global Co., Ltd.