HOO GARGLE ROOIBOS TEA 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.

----------

Hoo Gargle Rooibos Tea Flavor Active Ingredient

Sodium Flouride 0.02%

Hoo Gargle Rooibos Tea Flavor Purpose

anticavity

Hoo Gargle Rooibos Tea 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 Rooibos Tea 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 Rooibos Tea Flavor Indication

aids in the prevention of dental cavities

​​Hoo Gargle Rooibos Tea Flavor Inactive Ingredients

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, rooibos tea flavor

​​Hoo Gargle Rooibos Tea 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 Rooibos Tea Flavor

Hoo Gargle Rooibos Tea Flavor 15 packetsHoo Gargle Rooibos Tea Flavor 30 packetsHoo Gargle Rooibos Tea Flavor 50 packetsHoo Gargle Rooibos Tea Flavor 100 packets

HOO GARGLE ROOIBOS TEA FLAVOR 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83367-102
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
ALANINE (UNII: OF5P57N2ZX) 0.5 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) 0.6 mg  in 1 mL
XYLITOL (UNII: VCQ006KQ1E) 10 mg  in 1 mL
SODIUM ACETATE (UNII: 4550K0SC9B) 0.5 mg  in 1 mL
(2-AMINO-5,6-DICHLOROQUINAZOLIN-3(4H )-YL)ACETIC ACID (UNII: 03TUA9L576) 0.5 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83367-102-021 in 1 PACKAGE04/01/2023
1NDC:83367-102-0115 mL in 1 PACKET; Type 0: Not a Combination Product
2NDC:83367-102-041 in 1 PACKAGE04/01/2023
2NDC:83367-102-0330 mL in 1 PACKET; Type 0: Not a Combination Product
3NDC:83367-102-061 in 1 PACKAGE04/01/2023
3NDC:83367-102-0550 mL in 1 PACKET; Type 0: Not a Combination Product
4NDC:83367-102-081 in 1 PACKAGE04/01/2023
4NDC:83367-102-07100 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., LTD.695188803manufacture(83367-102)

Revised: 4/2023
Document Id: f92c5561-2a65-e7c0-e053-6294a90ada87
Set id: f92c5561-2a64-e7c0-e053-6294a90ada87
Version: 1
Effective Time: 20230412
 
Nuriearth Global Co., Ltd